Job Description
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
1. Provide day-to-day oversight of outsourced PV provider delivering:
2. Individual Case Safety Report (ICSR) management
3. Literature screening
4. Signal detection support
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