Pharmacovigilance (PV) Team Leader
hace 4 días
Ruislip
Job Purpose The Pharmacovigilance (PV) Team Leader is responsible for ensuring that the Marketing Authorisation Holder (MAH) meets all pharmacovigilance obligations in the UK and EU. This role provides operational and compliance oversight of outsourced pharmacovigilance service provider, ensuring that all PV activities are conducted in accordance with UK and EU legislation, GVP requirements, and company procedures. Key Responsibilities 1. MAH Pharmacovigilance Responsibilities (UK & EU) • Ensure the MAH fulfils all pharmacovigilance obligations in compliance with:, • EU GVP Modules, • UK Human Medicines Regulations and MHRA requirements, • Act as the MAH’s operational PV representative for UK and EU markets., • Ensure continuous compliance with PV legislation throughout the product lifecycle., • Support the Qualified Person for Pharmacovigilance (QPPV) / UK QPPV in maintaining oversight of the PV system., • Ensure appropriate PV agreements are in place and maintained with partners, distributors, and service providers. 2. Oversight of Outsourced Pharmacovigilance Service Provider • Provide day-to-day oversight of outsourced PV provider delivering:, • Individual Case Safety Report (ICSR) management, • Literature screening, • Signal detection support, • Aggregate reports (PSUR/PBRER, DSUR where applicable), • Monitor vendor performance against contractual obligations, KPIs, and SLAs., • Review and approve PV deliverables from service providers to ensure quality and compliance., • Lead regular vendor governance meetings and document outcomes., • Ensure issues, deviations, and CAPAs are appropriately managed and tracked. 3. Case Management & Safety Reporting Oversight • Ensure timely and compliant reporting of ICSRs to:, • EudraVigilance, • MHRA, • Other relevant authorities and partners, • Oversee case processing workflows, including:, • Case validation, • Medical review, • Regulatory submission timelines, • Ensure local reporting requirements in the UK and EU are met. 4. Safety Reporting & Risk Management • Oversee the review, and confirm submission of:, • PSURs / PBRERs, • Risk Management Plans (RMPs) and updates, • Signal management documentation, • Ensure safety signals are detected, evaluated, and escalated appropriately., • Support benefit-risk evaluations and safety communications as required. 5. PV Quality System & Compliance • Maintain and oversee the MAH PV Quality Management System., • Ensure PV SOPs are current, compliant, and effectively implemented., • Support PV inspections and audits by:, • MHRA, • EMA, • Partners or internal audit teams, • Manage inspection readiness activities, responses, and CAPAs., • Ensure PV training requirements are defined, delivered, and documented. 6. Cross-Functional & Regulatory Interaction • Act as a key PV contact for internal stakeholders including:, • Regulatory Affairs, • Quality, • Commercial, • Support regulatory submissions and variations from a PV perspective., • Ensure safety information is appropriately reflected in product information (SmPC, PIL). Qualifications & Experience Essential • Life science degree (e.g., Pharmacy, Medicine, Biomedical Science)., • Significant experience in pharmacovigilance within the UK and/or EU., • Strong knowledge of:, • EU GVP Modules, • UK PV legislation and MHRA requirements, • Demonstrated experience overseeing outsourced PV vendors., • Experience working within an MAH environment., • Familiarity with inspections and audits (MHRA, EMA, EU NCAs). Skills & Competencies • Strong regulatory and compliance mindset, • Excellent vendor management and communication skills, • Attention to detail and ability to manage multiple priorities, • Ability to work independently and make sound compliance-based decisions, • Strong documentation and review skills Desirable • Experience in both post-marketing and new submissions in the generic space, • Exposure to global PV operations, • Experience with electronic safety databases and EudraVigilance submissions
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