Experienced Pharmacovigilance Lead (Hybrid role) This is NOT an entry level role. At least 3-5 years PV experience in a CRO is required.
6 month initial Fixed Term Contract
Immediate start preferred
The Pharmacovigilance Lead provides operational and scientific leadership for assigned projects and/or functional PV activities, ensuring delivery of high‑quality, compliant PV services in accordance with the TMC PV QMS, contractual obligations, and regulatory expectations.
THIS IS A HYBRID ROLE: we expect the successful candidate be able to come to the office in Hartley Wintney, Hampshire, at least twice a week.
Role-specific tasks include;
Case processing, reporting and team management
- Responsible for day-to-day oversight of end-to-end case processing, including management of PV rota, functional guidance, and leadership of case processing team
- Management of case-processing flow, ensuring regulatory reporting compliance.
- Oversight of case-processing KPIs and maintaining and reporting on internal metrics and KPIs
- Provide expertise, support and active participation in case processing and routine departmental PV activities (e.g. MedDRA coding, eTMF, reconciliations)
- Promote a culture of quality, compliance, and continuous improvement within PV.
Operational PV activities
- Support PV Manager in preparation and maintenance of key client documentation (e.g. SMPs and PSMFS)
- Ensure PV deliverables are executed, and delivered in compliance with the TMC PV QMS, SOPs, and applicable regulations.
- Provide scientific and regulatory input into case management, aggregate reports, signal management, and risk management activities.
Quality and compliance
- Ensure inspection readiness for assigned projects, including support for audits and regulatory inspections.
- Review and approve PV documents (inc. Project-specific and departmental controlled documents), reports, and outputs in line with delegated authority.
- Identify, assess, and manage PV risks, deviations, and CAPAs, escalating issues as appropriate.
Client and stakeholder management
- Support PV managers as point of contact for assigned clients or internal stakeholders.
- Support PV governance activities, including oversight meetings, metrics review, and performance reporting.
Other key information:
Education and experience
- Advanced life sciences degree (or equivalent experience).
- Significant experience in pharmacovigilance within a CRO and/or MAH environment.
- Strong working knowledge of EU/UK GVP and global PV requirements.
Key competencies
- Proven leadership and decision‑making capability.
- Strong regulatory and scientific judgement.
- Excellent stakeholder and client management skills.
- Ability to balance operational delivery with quality and compliance oversight.