Associate Director or Director of Pharmacovigilance Operations

We need to output HTML fragment with sections: About the role? The posting includes description of company and role. We need headings:

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections that have real specific content. We have: - About the role: The paragraph describing the role: "Our Clinical Development team is seeking a highly motivated Associate Director/Director of Pharmacovigilance (PV) Operations. The ideal candidate will have a proven track-record of PV operations, including experience supporting the transition from clinical to commercial stage, and will be a hands-on leader who thrives in a fast paced and collaborative environment. This position reports to our VP of Drug Safety and Pharmacovigilance (DSPV) and is onsite 4 days/week in our office in Brighton, MA." That's about the role. - Responsibilities: The long list after "Responsibilities:" bullet points (though not bullet but sentences). We need to extract each duty as

. The responsibilities list is a paragraph with many semicolons? Actually it's a long sentence with many clauses separated by semicolons. We need to split into list items. We'll need to parse each responsibility. - Qualifications: The list after "Qualifications:" includes bullet-like sentences. We'll need to extract each qualification as

. - Skills: Not explicitly a separate heading, but qualifications include skills. Could we create a Skills section? The posting does not have a separate Skills heading; we should not create unless there is specific content. The qualifications include many skill-like items. But we can treat Qualifications as covering both qualifications and skills. The instruction says use headings for sections like Skills if present. Since not explicit, we may omit Skills. - Benefits: The paragraph after "Our mission is to bring transformative oncology therapies..." includes benefits description. That's specific content: comprehensive compensation and benefits package, base salary, discretionary bonus, equity, medical/dental/vision, HRA, FSA, gym membership, EAP, life insurance, 401(k) with 6% match, company parking, commuter reimbursement, vacation leave, summer Fridays, winter shut down week, training, tuition reimbursement, recognition awards, performance management, culture committee events, etc. So we can create Benefits section. - Pay: The posting includes "Base Salary Range in Job Post: $175,000 USD - $250,000 USD". That's specific pay info. So we need Pay section. - Schedule: The posting mentions "onsite 4 days/week in our office in Brighton, MA." That's schedule info. So we need Schedule section. We must not repeat job title as heading. No Job ID. We must not include boilerplate like EEO etc. Not present. We must output only HTML fragment. We need to wrap each section:

About the role

then

...

. For lists:

Responsibilities

• ...
...

. Similarly for Qualifications, Benefits, Pay, Schedule. We need to preserve all substantive information; do not invent or summarize away detail. Must not omit any detail. That's a lot; we need to include all responsibilities and qualifications verbatim (or close). We must be careful not to lose any detail. Let's extract responsibilities text exactly as given after "Responsibilities:" until before "Qualifications:" (the next heading). The responsibilities paragraph: "Ensure Compass Pharmacovigilance (PV) objectives are achieved in alignment with timelines, quality standards, applicable regulations, and commercial readiness requirementsStrategically lead the scale-up of Compass’ global PV operations infrastructure as the company transitions from a clinical-stage development pipeline to a commercial-stage companyManage scaling of PV operations, systems and processes, safety and vendor governance, risk management, internal and external partnerships, audit and inspection readiness, for commercial readiness in support of compliant regulatory filings and commercial launch; as detailed belowLead the design, implementation, and ongoing maintenance of the post-market PV system and associated Quality System to support upcoming marketing authorizations (NDA/MAA) and commercial readinessSupport the VP of Pharmacovigilance in safety evaluation, benefit-risk assessment, and compliance activities by providing pharmacovigilance operations expertiseServe as the company’s pharmacovigilance operations expert, maintaining current knowledge of drug safety requirements and identifying risks, gaps, and opportunities for improvementEstablish the PV operational governance framework, and optimize existing PV systems, processes, oversight of PV vendors, and infrastructure to support commercial readiness and scalable post-marketing commercial and medical strategiesServe as a core contributor to marketing authorization applications (NDA/MAA), co-authoring or reviewing clinical safety summaries, Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF), and other required safety documentationAuthor, enforce, and continuously improve internal PV policies, SOPs, charters, templates, forms, training materials, and meet global commercial Good Pharmacovigilance Practices (GVP)Draft and maintain Safety Data Exchange Agreements (SDEAs), safety product/project plans, quality processes, and related PV procedures, ensuring compliance by providing trainingDraft and negotiate SDEAs with global licensing partners and commercial distributors to establish clear responsibilities and timelines, to ensure safety data synchronizationOptimize safety databases by directing the configuration, validation, and overseeing ongoing use of databases (e.g., Argus, ARISg) to accommodate commercial data volumes and requirementsOversee PV operational support for active Phase I–III clinical trials, including safety management plan (SMP) execution, SAE reconciliation, case processing, and coordination with internal and external service providersLead the selection, qualification, contract negotiation, governance, and performance oversight of external PV vendors and CROs, including transition of vendor scopes from clinical-only to commercial case processing, escalating significant issues to the VP of Drug Safety/PVEstablish and monitor rigorous metrics-based PV Key Performance Indicators (KPIs) to assess vendor performance, quality, regulatory compliance, timeliness, and data integrity ensuring high-quality case management, inspection readiness, and delivery of contracted servicesCollaborate with internal and external stakeholders to bridge clinical trial safety workflows with commercial case-management realities and manage scaling vendor networksComply with PV regulatory timelines and meet corporate inspection readiness expectationsServe as the operational lead for pre-approval and post-approval regulatory inspections (FDA, EMA), coordinating preparation, responses, and follow-up activities for the PV functionOversee internal and external PV audits and investigations into late cases, deviations, or non-compliance, including implementation of robust Corrective and Preventive Action (CAPA) plansPartner cross-functionally with Clinical Development, Quality, Regulatory Affairs, Medical Affairs, Quality, and external vendors to integrate PV requirements and safety governance throughout drug development and corporate strategyLead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies" Note there is no punctuation between some sentences; we need to split into sensible list items. We can split at each capital letter start after a period? But there are missing periods. We'll need to infer boundaries. However we must preserve all substantive information; we can keep as one big paragraph? But requirement: Use

• for any list of duties/requirements/benefits. So we need to turn responsibilities into list items. We need to decide how to split. The text seems to be a series of responsibilities separated by semicolons or implied. Let's manually split based on logical breaks: 1. Ensure Compass Pharmacovigilance (PV) objectives are achieved in alignment with timelines, quality standards, applicable regulations, and commercial readiness requirements 2. Strategically lead the scale-up of Compass’ global PV operations infrastructure as the company transitions from a clinical-stage development pipeline to a commercial-stage company 3. Manage scaling of PV operations, systems and processes, safety and vendor governance, risk management, internal and external partnerships, audit and inspection readiness, for commercial readiness in support of compliant regulatory filings and commercial launch; as detailed below 4. Lead the design, implementation, and ongoing maintenance of the post-market PV system and associated Quality System to support upcoming marketing authorizations (NDA/MAA) and commercial readiness 5. Support the VP of Pharmacovigilance in safety evaluation, benefit-risk assessment, and compliance activities by providing pharmacovigilance operations expertise 6. Serve as the company’s pharmacovigilance operations expert, maintaining current knowledge of drug safety requirements and identifying risks, gaps, and opportunities for improvement 7. Establish the PV operational governance framework, and optimize existing PV systems, processes, oversight of PV vendors, and infrastructure to support commercial readiness and scalable post-marketing commercial and medical strategies 8. Serve as a core contributor to marketing authorization applications (NDA/MAA), co-authoring or reviewing clinical safety summaries, Risk Management Plans (RMPs), and Pharmacovigilance System Master File (PSMF), and other required safety documentation 9. Author, enforce, and continuously improve internal PV policies, SOPs, charters, templates, forms, training materials, and meet global commercial Good Pharmacovigilance Practices (GVP) 10. Draft and maintain Safety Data Exchange Agreements (SDEAs), safety product/project plans, quality processes, and related PV procedures, ensuring compliance by providing training 11. Draft and negotiate SDEAs with global licensing partners and commercial distributors to establish clear responsibilities and timelines, to ensure safety data synchronization 12. Optimize safety databases by directing the configuration, validation, and overseeing ongoing use of databases (e.g., Argus, ARISg) to accommodate commercial data volumes and requirements 13. Oversee PV operational support for active Phase I–III clinical trials, including safety management plan (SMP) execution, SAE reconciliation, case processing, and coordination with internal and external service providers 14. Lead the selection, qualification, contract negotiation, governance, and performance oversight of external PV vendors and CROs, including transition of vendor scopes from clinical-only to commercial case processing, escalating significant issues to the VP of Drug Safety/PV 15. Establish and monitor rigorous metrics-based PV Key Performance Indicators (KPIs) to assess vendor performance, quality, regulatory compliance, timeliness, and data integrity ensuring high-quality case management, inspection readiness, and delivery of contracted services 16. Collaborate with internal and external stakeholders to bridge clinical trial safety workflows with commercial case-management realities and manage scaling vendor networks 17. Comply with PV regulatory timelines and meet corporate inspection readiness expectations 18. Serve as the operational lead for pre-approval and post-approval regulatory inspections (FDA, EMA), coordinating preparation, responses, and follow-up activities for the PV function 19. Oversee internal and external PV audits and investigations into late cases, deviations, or non-compliance, including implementation of robust Corrective and Preventive Action (CAPA) plans 20. Partner cross-functionally with Clinical Development, Quality, Regulatory Affairs, Medical Affairs, Quality, and external vendors to integrate PV requirements and safety governance throughout drug development and corporate strategy 21. Lead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies That seems comprehensive. Now Qualifications section: after "Qualifications:" until before "Base Salary Range in Job Post:" (or before "Our mission is to bring transformative oncology therapies..."). Let's extract: "Bachelor’s degree in nursing (BSN), pharmacy, or a related healthcare/life science field required, Master’s degree in nursing (MSN) or an advanced degree preferred8+ years of progressive clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry is required; small company experiences preferredDirector-level candidates require 12+ years of experience, including positions of leadershipExperience working within a company transitioning from clinical to commercial stage, or direct experience launching a new commercial pharmaceutical asset3+ years of vendor oversight experience overseeing pharmacovigilance vendor performanceOncology experience preferredDeep expertise with and experience following regulations and guidelines for such as FDA, EMA, ICH, and global GVP regulations, including direct experience defending systems during regulatory agency inspectionsExpert-level knowledge