Overview
This role is a member of the GVP QA team providing global PV Quality Assurance oversight of Alnylam’s post‑marketing pharmacovigilance system, with a focus on PV audit execution, vendor quality oversight, CAPA management, and PSMF support. The role leads and executes the global PV audit program and partners cross‑functionally to strengthen PV quality processes.
This position reports to the Associate Director, Global PV Quality Assurance and frequently interacts with cross‑functional teams.
This role is hybrid, working 2 days per week based in either the Maidenhead, UK or Amsterdam, The Netherlands office.
Key Responsibilities
* Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system through PV quality audits, risk‑based quality oversight, and continuous improvement of PV processes.
* 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.
* Lead and execute global PV quality audits for licensing partners, external PV vendors, internal functions, affiliates, and other applicable service providers in a post‑marketing environment.
* Determine, evaluate and investigate Quality Events, and assess adequacy of root‑cause analyses and CAPAs, applying risk‑based thinking to determine required actions.
* Effectively communicate and escape critical matters to management.
* Own and drive the Global PV Strategic Audit Program, including development of risk‑based PV audit strategy, maintenance of the PV audit universe and risk tools, and creation of global PV audit plans and schedules.
* Determine, evaluate and investigate PV Quality Events, and own and drive root‑cause analysis, CAPA development, implementation, and effectiveness checks for PV audits and vendor oversight activities.
* Support the Global Strategic Audit Program – contribute to risk‑based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
* Own and execute PVQA contributions to the PV System Master File (PSMF), including compiling, maintaining and providing audit, CAPA and supplier quality information to ensure comprehensive and accurate PSMF content.
* Develop and maintain processes and tools to support quality audit execution and outcomes.
* Act as the primary operational PVQA owner and QA contact for global PV, PMS, and PV‑related vendors, including audit planning and execution, CAPA management, and ongoing vendor quality oversight.
* 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.
Qualifications
* Educated to university degree (preferably life sciences) or equivalent qualification or experience.
* Extensive experience in the pharmaceutical industry within global Pharmacovigilance Quality Assurance (PVQA), including PV audit execution and vendor quality oversight.
* Audit skills and experience of conducting GVP audits is preferred.
* Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidance and ICH.
* Experience supporting Health Authority inspections.
* Self‑motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
* Strong interpersonal, verbal and written communication skills, building positive and productive working relationships.
* Diplomatic in addressing sensitive issues confidentially and professionally, handling confidential information responsibly.
* Ability to analyse complex situations/issues and demonstrate strategic thinking.
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