Associate Director, Pharmacovigilance (Remote – Ireland / UK)
Employer: Leading Life Sciences Consultancy (via Thornshaw Recruitment)
Location: Remote – Ireland or United Kingdom
Work Mode: Remote
Salary / Compensation: Negotiable (not disclosed in the description)
Job Summary
A life sciences consultancy is seeking an Associate Director, Pharmacovigilance to own PV strategy, compliance, operations, team growth, and profitability. You will act as the internal and external PV subject matter expert, ensure a robust Pharmacovigilance System (aligned with EU GVP, MHRA/HPRA expectations), lead inspections/audits, drive business development, and represent the function at senior leadership level. Ideal for an experienced PV leader with strong people management, commercial acumen, and end‑to‑end PV governance expertise. Eligibility to act as QPPV is a plus.
Key Responsibilities
Provide departmental leadership, direction, and P&L accountability; drive growth and profitability.
Ensure Pharmacovigilance requirements are fully met and a compliant PV System (PSMF, procedures, KPIs, CAPA) is maintained.
Serve as PV SME internally and externally; present to senior leadership and contribute to corporate strategy.
Build, coach, and retain a high‑performing PV team; set PDP goals, monitor delivery, and nurture an inclusive, collaborative culture.
Develop, implement, and continuously improve PV policies, SOPs, and quality frameworks in line with GVP Modules I–XVI and local legislation.
Lead PV audits, MHRA/HPRA inspections, readiness activities, responses, and CAPA oversight.
Represent the company in public forums, negotiations with clients/suppliers, and key stakeholder engagements.
Partner with BD/Commercial to shape and execute business development strategy, contributing to proposals, pricing, and contract terms.
Oversee budgeting, resource planning, performance management, and operational excellence.
Promote cross‑company teamwork and knowledge sharing across all subsidiaries.
Required Skills & Qualifications
Relevant life sciences or healthcare degree (e.g., Pharmacy, Medicine, Life Sciences).
Proven pharmacovigilance leadership experience in industry or consultancy.
Strong people leadership, organizational agility, and change management skills.
Deep knowledge of EU/UK PV legislation, GVP, PV System Master File (PSMF), signal detection, aggregate reporting (PSUR/PBRER), RMP, ICSRs, CAPA, and inspection management.
Commercial and financial acumen (budgeting, pricing, margin, P&L ownership).
Excellent stakeholder management, communication, and presentation skills at executive level.
Desirable: Eligible/experienced to be named as Qualified Person Responsible for Pharmacovigilance (QPPV).
(PV tools and frameworks you should be comfortable with: MedDRA, EudraVigilance, XEVMPD, Argus/ArisG (or similar PV safety databases), ICSR processing workflows, aggregate report authoring platforms, KPI dashboards.)
Perks & Benefits
Fully remote role (Ireland or UK).
Senior leadership seat with strategic influence on PV operations, compliance, and growth.
Opportunity to build, mentor, and scale a PV team within a growing consultancy.
Ongoing leadership and functional training.
Exposure to diverse clients, portfolios, and therapeutic areas.
Company Description
Thornshaw Recruitment, part of the CPL Group, is partnering with a leading life sciences consultancy that delivers end-to-end pharmacovigilance, regulatory, and quality solutions to global biopharma. The firm is committed to compliance excellence, operational scalability, and patient safety across the product lifecycle.
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