Drug Safety Specialist
4 days ago
Hook
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), • 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., • 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., • 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., • 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.