Senior Director, Drug Safety and Pharmacovigilance Operations
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text. Prefer few substantive sections over many thin ones.
We need to parse the posting.
Content:
- Intro paragraph about Spyre Therapeutics (company description). Could be "About the role"? Actually "Role Summary" is a paragraph. Could be "About the role" heading.
- Then "Key Responsibilities" with sub-sections: Case Management and Safety Systems, Vendor and Operational Governance, Safety Data, Surveillance, and Reporting, Quality, Compliance, and Inspection Readiness, Systems, Documentation, and Business Continuity, Training, Other.
- Then "Ideal Candidate" with bullet list of qualifications (Master's degree, etc). Could be "Requirements" or "Qualifications". We'll decide.
- Then "What We Offer" with bullet list of benefits: Opportunity to work..., Market competitive compensation..., Unlimited PTO, Two, one-week company-wide shutdowns each, Commitment to provide professional development opportunities, Remote working environment with frequent in-person meetings..., The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
- Then EEO boilerplate and scam warning etc to be removed.
Thus sections: About the role (role summary), Responsibilities (key responsibilities), Requirements (ideal candidate), Benefits (what we offer), Pay (salary range). Possibly Schedule? Not present. So we omit Schedule.
We need to use
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive information, not invent or summarize away detail. So we need to include all details from responsibilities, ideal candidate, what we offer, salary range.
We must not include boilerplate like EEO, scam warning, etc.
We must not duplicate lines.
We need to format responsibilities as lists. The responsibilities have subheadings (Case Management and Safety Systems, etc). Should we treat each subheading as a heading? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It seems they want only those top-level sections. Within Responsibilities we can have prose or lists. Could embed subheadings as or just plain text? Probably we can keep them as part of list items or paragraphs. But we need to preserve all substantive information; we can include subheadings as plain text within or
- . Since they said use
for section headings (list given). So we should not create additional beyond those. So within Responsibilities we can have paragraphs describing each area, maybe using
with bold headings.
Simplify: For Responsibilities, we can produce a
where each - contains the responsibility area description (including subpoints). But we need to preserve details like "Provide oversight of end-to-end case processing..." etc. Could break into multiple
- items for each bullet under each subheading.
Let's extract responsibilities details:
Under "Key Responsibilities":
- Case Management and Safety Systems
* Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
* Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
* Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
* Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
* Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
* Serve as the unblinded Drug Safety Operations representative, as required.
- Vendor and Operational Governance
* Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
* Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
* Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
* Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
* Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.
- Safety Data, Surveillance, and Reporting
* Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
* Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
* Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
* Support identification and evaluation of emerging safety concerns
* Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
* Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
* Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.
- Quality, Compliance, and Inspection Readiness
* Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
* Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
* Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
* Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
* Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.
- Systems, Documentation, and Business Continuity
* Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
* Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
* Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.
- Training
* Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
* Oversee vendor training programs and monitor training completion and compliance.
- Other
* Perform other duties as assigned.
Now Ideal Candidate:
- Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
We can put these as
- under Requirements.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
- The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
We need a Pay section for salary range. Could be separate
Pay
with containing that sentence. Benefits section can include the other bullet points (excluding salary). Or we could combine Benefits and Pay but instruction says prefer few substantive sections; we could have Benefits include salary range as part of benefits. But they said include Pay section only if posting actually states them. It does state salary range. So we can have a Pay section.
Thus sections: About the role (role summary paragraph), Responsibilities (list of duties), Requirements (list of qualifications), Benefits (list of offerings except salary), Pay (salary range). Possibly also include "What We Offer" as Benefits.
We need to avoid duplication: The salary line also appears in Benefits bullet? Actually the bullet list includes "Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits." That's separate from salary range. So we keep that in Benefits.
Now produce HTML.
Structure:
About the role
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Role Summary The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices. Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning. Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP). As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text. Prefer few substantive sections over many thin ones. We need to parse the posting. Content: - Intro paragraph about Spyre Therapeutics (company description). Could be "About the role"? Actually "Role Summary" is a paragraph. Could be "About the role" heading. - Then "Key Responsibilities" with sub-sections: Case Management and Safety Systems, Vendor and Operational Governance, Safety Data, Surveillance, and Reporting, Quality, Compliance, and Inspection Readiness, Systems, Documentation, and Business Continuity, Training, Other. - Then "Ideal Candidate" with bullet list of qualifications (Master's degree, etc). Could be "Requirements" or "Qualifications". We'll decide. - Then "What We Offer" with bullet list of benefits: Opportunity to work..., Market competitive compensation..., Unlimited PTO, Two, one-week company-wide shutdowns each, Commitment to provide professional development opportunities, Remote working environment with frequent in-person meetings..., The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. - Then EEO boilerplate and scam warning etc to be removed. Thus sections: About the role (role summary), Responsibilities (key responsibilities), Requirements (ideal candidate), Benefits (what we offer), Pay (salary range). Possibly Schedule? Not present. So we omit Schedule. We need to use
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive information, not invent or summarize away detail. So we need to include all details from responsibilities, ideal candidate, what we offer, salary range.
We must not include boilerplate like EEO, scam warning, etc.
We must not duplicate lines.
We need to format responsibilities as lists. The responsibilities have subheadings (Case Management and Safety Systems, etc). Should we treat each subheading as a heading? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It seems they want only those top-level sections. Within Responsibilities we can have prose or lists. Could embed subheadings as or just plain text? Probably we can keep them as part of list items or paragraphs. But we need to preserve all substantive information; we can include subheadings as plain text within or
- . Since they said use
for section headings (list given). So we should not create additional beyond those. So within Responsibilities we can have paragraphs describing each area, maybe using
with bold headings.
Simplify: For Responsibilities, we can produce a
where each - contains the responsibility area description (including subpoints). But we need to preserve details like "Provide oversight of end-to-end case processing..." etc. Could break into multiple
- items for each bullet under each subheading.
Let's extract responsibilities details:
Under "Key Responsibilities":
- Case Management and Safety Systems
* Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
* Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
* Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
* Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
* Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
* Serve as the unblinded Drug Safety Operations representative, as required.
- Vendor and Operational Governance
* Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
* Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
* Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
* Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
* Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.
- Safety Data, Surveillance, and Reporting
* Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
* Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
* Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
* Support identification and evaluation of emerging safety concerns
* Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
* Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
* Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.
- Quality, Compliance, and Inspection Readiness
* Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
* Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
* Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
* Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
* Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.
- Systems, Documentation, and Business Continuity
* Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
* Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
* Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.
- Training
* Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
* Oversee vendor training programs and monitor training completion and compliance.
- Other
* Perform other duties as assigned.
Now Ideal Candidate:
- Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
We can put these as
- under Requirements.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
- The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
We need a Pay section for salary range. Could be separate
Pay
with containing that sentence. Benefits section can include the other bullet points (excluding salary). Or we could combine Benefits and Pay but instruction says prefer few substantive sections; we could have Benefits include salary range as part of benefits. But they said include Pay section only if posting actually states them. It does state salary range. So we can have a Pay section.
Thus sections: About the role (role summary paragraph), Responsibilities (list of duties), Requirements (list of qualifications), Benefits (list of offerings except salary), Pay (salary range). Possibly also include "What We Offer" as Benefits.
We need to avoid duplication: The salary line also appears in Benefits bullet? Actually the bullet list includes "Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits." That's separate from salary range. So we keep that in Benefits.
Now produce HTML.
Structure:
About the role
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Role Summary The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices. Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning. Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP). As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This
for prose. We must preserve all substantive information, not invent or summarize away detail. So we need to include all details from responsibilities, ideal candidate, what we offer, salary range. We must not include boilerplate like EEO, scam warning, etc. We must not duplicate lines. We need to format responsibilities as lists. The responsibilities have subheadings (Case Management and Safety Systems, etc). Should we treat each subheading as a heading? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It seems they want only those top-level sections. Within Responsibilities we can have prose or lists. Could embed subheadings as or just plain text? Probably we can keep them as part of list items or paragraphs. But we need to preserve all substantive information; we can include subheadings as plain text within or
- . Since they said use
for section headings (list given). So we should not create additional beyond those. So within Responsibilities we can have paragraphs describing each area, maybe using
with bold headings.
Simplify: For Responsibilities, we can produce a
where each - contains the responsibility area description (including subpoints). But we need to preserve details like "Provide oversight of end-to-end case processing..." etc. Could break into multiple
- items for each bullet under each subheading.
Let's extract responsibilities details:
Under "Key Responsibilities":
- Case Management and Safety Systems
* Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
* Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
* Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
* Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
* Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
* Serve as the unblinded Drug Safety Operations representative, as required.
- Vendor and Operational Governance
* Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
* Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
* Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
* Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
* Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.
- Safety Data, Surveillance, and Reporting
* Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
* Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
* Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
* Support identification and evaluation of emerging safety concerns
* Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
* Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
* Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.
- Quality, Compliance, and Inspection Readiness
* Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
* Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
* Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
* Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
* Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.
- Systems, Documentation, and Business Continuity
* Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
* Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
* Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.
- Training
* Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
* Oversee vendor training programs and monitor training completion and compliance.
- Other
* Perform other duties as assigned.
Now Ideal Candidate:
- Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
We can put these as
- under Requirements.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
- The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
We need a Pay section for salary range. Could be separate
Pay
with containing that sentence. Benefits section can include the other bullet points (excluding salary). Or we could combine Benefits and Pay but instruction says prefer few substantive sections; we could have Benefits include salary range as part of benefits. But they said include Pay section only if posting actually states them. It does state salary range. So we can have a Pay section.
Thus sections: About the role (role summary paragraph), Responsibilities (list of duties), Requirements (list of qualifications), Benefits (list of offerings except salary), Pay (salary range). Possibly also include "What We Offer" as Benefits.
We need to avoid duplication: The salary line also appears in Benefits bullet? Actually the bullet list includes "Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits." That's separate from salary range. So we keep that in Benefits.
Now produce HTML.
Structure:
About the role
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Role Summary The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices. Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning. Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP). As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This
for section headings (list given). So we should not create additional beyond those. So within Responsibilities we can have paragraphs describing each area, maybe using
with bold headings. Simplify: For Responsibilities, we can produce a
- where each
- contains the responsibility area description (including subpoints). But we need to preserve details like "Provide oversight of end-to-end case processing..." etc. Could break into multiple
- items for each bullet under each subheading.
Let's extract responsibilities details:
Under "Key Responsibilities":
- Case Management and Safety Systems
* Provide oversight of end-to-end case processing for clinical development programs, ensuring timely, accurate, and compliant collection, review, processing, follow-up, reconciliation, and reporting of safety information.
* Serve as the operational subject matter expert and lead for the Argus global safety database, including workflows, vendor activities, data outputs, reporting, system compliance, and applicable business-continuity and disaster-recovery processes.
* Oversee expedited safety reporting, including SUSAR submissions, in accordance with applicable regulatory requirements and timelines.
* Establish and monitor case-processing workflows, KPIs, compliance metrics, and operational deliverables; review and escalate performance issues and trends.
* Monitor safety operations performed by PSPs, vendors, and business partners for compliance with protocols, SMPs, VOPs, SOPs, work instructions, study plans, contracts, and applicable regulations.
* Serve as the unblinded Drug Safety Operations representative, as required.
- Vendor and Operational Governance
* Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
* Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
* Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
* Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
* Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.
- Safety Data, Surveillance, and Reporting
* Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
* Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
* Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
* Support identification and evaluation of emerging safety concerns
* Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
* Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
* Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.
- Quality, Compliance, and Inspection Readiness
* Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
* Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
* Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
* Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
* Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.
- Systems, Documentation, and Business Continuity
* Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
* Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
* Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.
- Training
* Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
* Oversee vendor training programs and monitor training completion and compliance.
- Other
* Perform other duties as assigned.
Now Ideal Candidate:
- Master’s degree in relevant field (Life sciences) or equivalent combination of education and experience; nursing degree (RN) or pharmacy degree (PharmD) preferred
- Minimum of eight years of experience in pharmacovigilance operations or a related function within the biotechnology or pharmaceutical industry.
- Hands-on experience with global safety databases, preferably Argus, and safety-data analytics.
- Demonstrated experience with case processing, safety-database oversight, vendor governance, audit and inspection readiness, and budget and invoice management.
- Experience managing and providing oversight of pharmacovigilance service providers and safety-database hosting partners.
- Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations and requirements.
- Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
We can put these as
- under Requirements.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
- The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
We need a Pay section for salary range. Could be separate
Pay
withcontaining that sentence. Benefits section can include the other bullet points (excluding salary). Or we could combine Benefits and Pay but instruction says prefer few substantive sections; we could have Benefits include salary range as part of benefits. But they said include Pay section only if posting actually states them. It does state salary range. So we can have a Pay section. Thus sections: About the role (role summary paragraph), Responsibilities (list of duties), Requirements (list of qualifications), Benefits (list of offerings except salary), Pay (salary range). Possibly also include "What We Offer" as Benefits. We need to avoid duplication: The salary line also appears in Benefits bullet? Actually the bullet list includes "Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits." That's separate from salary range. So we keep that in Benefits. Now produce HTML. Structure:
About the role
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Role Summary The Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations will provide operational leadership for pharmacovigilance activities, including case management, vendor governance, regulatory compliance, the PV Quality Management System (QMS), inspection and audit readiness, training, and performance metrics. This individual will also oversee DSPV contracts, budgets, and invoices. Serving as the subject matter expert for outsourced safety operations, the Senior Director will oversee case processing, expedited reporting, and activities related to the Argus global safety database (GSDB), including reporting, business continuity, and disaster-recovery planning. Responsible for reports preparation and vendor management for GSDB related activities. Serves as lead for PV compliance, QMS, and inspection /audit readiness for the DSPV function, and for the organization and oversight of the Safety Management Plans (SMP), Safety Management Team (SMT) meetings, Vendor Oversight Plan (VOP). As the case management lead, the Senior Director will monitor case-processing activities performed by patient support programs (PSPs), vendors, and business partners. This
- under Requirements.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
- The expected salary range offer for this role is $295,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
We need a Pay section for salary range. Could be separate