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.