Senior Pharmacovigilance Specialist
About this role
Job Description
Senior Pharmacovigilance (PV) Specialist
We’re seeking a hands-on Senior PV Specialist to join our UK & Ireland country operations team. You’ll take ownership of local PV activities, keep us compliant, and be a trusted partner to local business teams. On a day-to-day basis you’ll support the management of local initiatives and data sources, assist with audits and inspections, maintain PV systems and documentation, and oversee ARMM and RMP activities.
This role suits someone who is organised, proactive and enjoys working across functions and with global PV stakeholders. In a challenging, fast‑moving environment you’ll make a direct impact, solve complex problems and grow your PV expertise.
What you’ll do
:
Execute local PV processes and ensure compliance with local legislation and global procedures (AE case handling, aggregate reports, patient programmes, local PV agreements).
Support the management of adverse event intake, triage, follow-up and submissions.
Support PV audits, inspections and self-inspections; contribute to development and closure of CAPAs.
Maintain local PV documents, training materials and local training resources; support onboarding of new colleagues.
Support aggregate report operations; scheduling, coordinating and maintaining timely submission of aggregate safety reports
Implement local Risk Management Plans (RMPs) and associated risk-minimisation activities.
Implement and oversee Risk Minimisation Measures and Additional Risk Minimisation Measures.
Monitor Health Authority communications and advise stakeholders; represent PV in cross-functional meetings.
Review local initiatives (marketing, patient programmes, digital tools) for PV compliance.
Support business continuity plans and participate in projects that improve PV processes.
What we need from you:
Education
Degree in health, life sciences or medical sciences, or equivalent experience.
Requirements
- Extensive PV experience in the pharmaceutical industry preferred (or equivalent experience)
- .
- Strong knowledge of AE reporting, UK and EU PV regulations and PV quality systems.
- Experience with PV audits or Health Authority inspections preferred.
- Key skills
- Fluent in English (written and spoken).
- Excellent communication and stakeholder-management skills.
- Strong organisation, prioritisation and project-management abilities.
- Comfortable working independently and collaborating across functions.
- Effective negotiation and influencing skills; able to drive improvements.
- Strategic mindset with a strong attention to quality and regulatory compliance.
Nice to have
- Previous experience in the UK Pharmacovigilance environment
- Experience with ARMM and RMP activities
- Why join us:
- You will play a visible role in keeping patients safe and enabling our business teams to operate with confidence. We offer opportunities to lead projects, develop professionally and work with a collaborative, cross functional team.
- Closing date for applications: 22/05/2026
- Required Skills:
- Compliance Monitoring, Cross-Functional Collaboration, Data Analysis, Drug Safety Surveillance, Patient Safety, Pharmaceutical Management, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Risk Management, Safety Procedures, Stakeholder Management
- Preferred Skills:
- Current Employees apply
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- Current Contingent Workers apply
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- Search Firm Representatives Please Read Carefully
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
- Employee Status:
- Regular