Associate Director Pharmacovigilance
Reporting into the Global Head of Medical Safety, the Associate Director will function as a safety physician within the global PV team for the assigned therapeutic areas.
The contributions of the Associate Director brings the European needs and requirements as well as the European perspective on medical aspects and EU healthcare systems to the global team. A key element thereby is a good understanding of clinical practice in Europe. The Associate Director contributes to aggregate reports, risk management plans and risk minimisation activities, performs medical reviews of individual case safety reports, is involved in signal detection activities, contributes to marketing authorisation applications and responds to health authority requests.
Key Activities will include the following:
- Participating in the conduct of Pharmacovigilance for assigned products or projects including medical assessments, on-going safety evaluation and signal detection as part of the global Pharmacovigilance organisation
- Interacting with EMA, NCAs, Region Europe Affiliates, partners and service providers.
- Contributing to and reviewing key Pharmacovigilance documents such as PSURs, CCSIs, Risk Management Plans, safety sections of SmPCs, IBs, Clinical Trial/ Study Protocols, and Final Reports.
- Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable.
- On assignment: Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues
This is a superb new and exciting opportunity for a PV professional to really get involved and develop their career.
For further information, please do not hesitate to contact Kathryn Taylor or apply today.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Our client, one of the world’s largest pharmaceutical organisations, is responsible for developing and manufacturing medicines and vaccines for a wide range of medical disciplines. They have
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