- Support the UK RPP in maintaining an effective pharmacovigilance system in compliance with MHRA requirements.
- Assist in ensuring continuous oversight of all PV activities performed internally and by third parties.
- Support regulatory inspections, audits, and CAPA management.
- Contribute to PV governance activities and safety compliance monitoring.
- Provide oversight of Medical Information activities to ensure compliance with pharmacovigilance obligations.
- Ensure product complaints, adverse events, special situations, and safety information received through Medical Information are appropriately identified, processed, and reported.
- Support and perform reconciliation activities between Medical Information and other stakeholders
- Ensure deviation, CAPA, change control, and risk management processes.
- Drive inspection readiness activities across the PV system.
- Deliver pharmacovigilance training to internal stakeholders
- Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with regulatory requirements.
- Preparation and implementation and maintenance of approved RMM programmes.
- Coordinate the preparation, review, UK PSMF and all associated annexes.
- Ensure the PSMF accurately reflects the current pharmacovigilance system and organisational structure.
- Oversight and management of safety variations
Qualification:
- Essential Degree in Life Sciences, Pharmacy, Nursing, Medicine, or related healthcare discipline.
- Significant pharmacovigilance experience within the pharmaceutical industry.
- Strong knowledge of UK Pharmacovigilance legislation and MHRA GVP requirements.
Job Types: Permanent, Full-time
Pay: £28,000.00-£35,000.00 per year
Benefits:
- Company events
- Company pension
- Life insurance
- On-site parking
- Sick pay
Ability to commute/relocate:
- Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)
Education:
Licence/Certification:
- UK Work Authorisation (required)
Work Location: In person
