Pharmacovigilance Manager UK & Ireland

As Pharmacovigilance Manager UK & Ireland you will ensure that collection, reporting and handling of safety information associated with Servier’s products is organised and performed according to global Servier and local regulatory requirements.  You will maintain oversight of safety risk management and all other pharmacovigilance activities and ensure pharmacovigilance compliance and inspection readiness across all affiliate functions.

Key responsibilities

• Local Pharmacovigilance System Setup: Coordinate and organize pharmacovigilance activities at the national/area level in liaison with Global Safety.
• Local QPPV Duties: Act as the nominated person for local competent authority as required by local regulations.
• Management of PV Cases: Handle pharmacovigilance cases per internal procedures.
• PSMF Maintenance: Maintain Pharmacovigilance System Master File as required.
• Literature Surveillance: Screen local scientific journals and process identified ICSRs.
• Management of Key Interfaces: Ensure oversight and reconciliation of interfaces that are potential sources of PV cases.
• Study and Program Oversight: Implement appropriate safety reporting processes for interventional and non-interventional studies and compassionate use.

• Management of Aggregate Reports: Provide safety-related information for Aggregate Reports (writing/tracking) and ensure their submission to local regulatory authorities.
• Oversight of RMP and RMM Implementation: Monitor Risk Management Plan implementation and follow up on additional Risk Minimization Measures.
• Signal Detection: Conduct local signal detection activities and communicate potential safety signals to Global Safety.
• Safety Communication: Respond to safety queries and significant safety issues according to Global processes and local regulatory requirements.
• Labelling and Commitments: Contribute to local safety label updates and implementation of commitments.

• Pharmacovigilance Quality System: Implement and maintain a local Pharmacovigilance Quality System and ensure training compliance.
• Local Pharmacovigilance Agreement: Negotiate and write local pharmacovigilance agreements with partners and service providers.
• Business Continuity: Ensure continuity of pharmacovigilance activities, including out-of-business hours coverage.
• Regulatory Intelligence: Monitor updates in local legislation, perform impact analysis and inform Global Safety of changes.
• Archiving: Ensure PV documents are archived according to regulatory requirements.
• Audit and Inspection: Prepare for audits and inspections, ensuring implementation of CAPA plans within defined timelines.
• Management of Local PV Unit: Lead and motivate the local pharmacovigilance team and ensure proper resourcing of activities.

Education:  

Bachelor’s degree in life sciences, pharmacy or a related field

Experience:  

Minimum 5 years in pharmacovigilance including QPPV role

Strong knowledge of pharmacovigilance principles and regulatory requirements

A collaborative, solution-focused approach with the ability to work autonomously and within a team.

Commitment to ethical leadership, patient safety, and continuous improvement.

This position is based at our head office in Stoke Poges, Slough, with hybrid options available to work from home up to 2 days per week.

You must be able to start working with us no later than the beginning of December 2025.