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Job Description

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

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.

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