Global Pharmacovigilance Quality Assurance Senior Manager

We need to output HTML fragment with sections: About the role? The posting includes Title, Location, Duration, Additional Information, Responsibilities (with Summary of Key Responsibilities), Requirements and Skills, Why TalentBurst? (but that's boilerplate about the staffing agency; we should remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "Why TalentBurst?" is likely boilerplate about the staffing agency; we should remove it. Also "Additional Information" includes location preferences; we can fold into a short

maybe under About the role? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Thus we need sections: About the role (maybe include location, duration, additional info), Responsibilities, Requirements and Skills (maybe combine Requirements and Skills). No Benefits, Pay, Schedule because not stated. Also maybe Qualifications? The posting has "Requirements and Skills:" which includes education, experience, audit skills, etc. Could treat as Requirements. Could also have Skills subsection but we can combine. We must not invent sections. So we will output:

  About the role

  Tech Ops and Quality - Senior Manager, Global Pharmacovigilance (PV) Quality Assurance. Location: Cambridge, MA OR Remote. Duration: 6 Months. Additional Information: Philadelphia or Cambridge-area candidates are welcome/preferred. Remote candidates may also be considered, with preference for EST/CST time zones. Candidate must be able to work East Coast hours and be available for occasional travel related to audits.

  Then Responsibilities: we have a long paragraph with bullet-like sentences. We need to convert to
  • for any list of duties/requirements/benefits. The responsibilities are a series of sentences separated by periods. We can split each responsibility into a list item. Must preserve all substantive information. So we need to extract each duty. Let's parse responsibilities text: "This role is a member of the GVP QA team providing Quality oversight of Alnylam's global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to Alnylam's Inspection activities. This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams (which are generally termed Expertise Areas, EA, at Alnylam). Summary of Key Responsibilities: Senior Manager, PV QA supports all the GVP QA's responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will lead specific activities:Serve as a strong partner with EAs in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).Support cross-GxP QA activities requiring PV and PMS expertise.Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Apply risk-based thinking in determining required actions.Effectively communicate and escalate critical matters to management.Support the Global Strategic Audit Program — contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools, and support lifecycle management of PV audit schedule. Support audit conduct which may include preparation and planning of audits, conduct of audits remotely and in person, reporting audits and close out of audit findings, including CAPA management.Provide QA Audit, CAPA, and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.Develop and maintain processes and tools to support quality audit execution and outcomes.Support PV/post-marketing surveillance inspection readiness and inspection management activities.Provide Quality oversight of PV, PMS, and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs, and audits.Develop and report GVP QA metrics and dashboards to support quality oversight.Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions.Other assignments as directed." We need to split into list items. Each sentence after "Senior Manager will lead specific activities:" seems to be a duty. Also earlier sentences about role overview could be included as list items or as prose? The instruction: Use
    • for any list of duties/requirements/benefits, and

      for prose. So we could put the overview as a

      then list duties as

      . But we must preserve all substantive information. Let's decide: We'll put a brief overview paragraph then a
      of responsibilities. Overview: "This role is a member of the GVP QA team providing Quality oversight of Alnylam's global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to Alnylam's Inspection activities. This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams (which are generally termed Expertise Areas, EA, at Alnylam)." Then list items for each duty after "Senior Manager will lead specific activities:" plus maybe the "Summary of Key Responsibilities:" sentence is just intro. Let's extract duties: 1. Serve as a strong partner with EAs in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents. 2. Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP). 3. Support cross-GxP QA activities requiring PV and PMS expertise. 4. Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment. 5. Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Apply risk-based thinking in determining required actions. 6. Effectively communicate and escalate critical matters to management. 7. Support the Global Strategic Audit Program — contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools, and support lifecycle management of PV audit schedule. Support audit conduct which may include preparation and planning of audits, conduct of audits remotely and in person, reporting audits and close out of audit findings, including CAPA management. 8. Provide QA Audit, CAPA, and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data. 9. Develop and maintain processes and tools to support quality audit execution and outcomes. 10. Support PV/post-marketing surveillance inspection readiness and inspection management activities. 11. Provide Quality oversight of PV, PMS, and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs, and audits. 12. Develop and report GVP QA metrics and dashboards to support quality oversight. 13. Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs. 14. Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions. 15. Other assignments as directed. We need to keep the ampersand dash as — but HTML entity is fine. Now Requirements and Skills: We'll make a section

      Requirements and Skills

      and then a
      list. Extract requirements: - Educated to university degree (preferably life sciences) or equivalent qualification or experience. - Extensive experience in the pharmaceutical industry in a quality or compliance function. - Audit skills and experience conducting GVP audits is preferred. - Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances, and ICH. - Experience supporting Health Agency inspections. - Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement. - Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships. - Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information. - Ability to analyze complex situations/issues. Demonstrates strategic thinking. We could combine some sentences into list items. Now we must not include "Why TalentBurst?" etc. Also we should not include any boilerplate like "At TalentBurst, we deliver more than talent..." etc. Thus final HTML fragment:

      About the role

      Tech Ops and Quality - Senior Manager, Global Pharmacovigilance (PV) Quality Assurance. Location: Cambridge, MA OR Remote. Duration: 6 Months. Additional Information: Philadelphia or Cambridge-area candidates are welcome/preferred. Remote candidates may also be considered, with preference for EST/CST time zones. Candidate must be able to work East Coast hours and be available for occasional travel related to audits.

      Responsibilities

      • Serve as a strong partner with EAs in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
      • Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).
      • Support cross-GxP QA activities requiring PV and PMS expertise.
      • Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
      • Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Apply risk-based thinking in determining required actions.
      • Effectively communicate and escalate critical matters to management.
      • Support the Global Strategic Audit Program — contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools, and support lifecycle management of PV audit schedule. Support audit conduct which may include preparation and planning of audits, conduct of audits remotely and in person, reporting audits and close out of audit findings, including CAPA management.
      • Provide QA Audit, CAPA, and Supplier data for the PV System Master File (PSMF).