Pharmacovigilance Manager

1 year Fixed Term Contract- Pharmacovigilance Manager. Hybrid role: Office (Hartley Wintney, Hampshire): home-based.

Summary of Responsibilities:

1. The PV Manager has overall responsibility for the conduct and delivery of their client’s PV activities and deliverables within TMC PV, as well as input to the development and maintenance of TMC PV’s key systems.
2. The post-holder is responsible for providing support and input to PV advice given to clients and colleagues on challenging, multi-geography projects; and helping to translate client requirements into tangible actions.
3. Involved within TMC at an operational level, the PV Manager will also be responsible for the timely delivery of assigned PV projects and individual case management with regards to quality and compliance, adhering to company standards for pharmacovigilance, both in clinical trials and with approved/marketed products.
4. The post-holder will also support the preparation and maintenance of essential PV documents such as periodic reports, RMPs, PSMF, as well as PV activities including benefit-risk monitoring and signal detection.

Essential Qualifications, Experience and Technical Skills:

• Relevant degree in a Life Science discipline or equivalent
• Expertise in Pharmacovigilance in the Pharmaceutical Industry including working within regional and global regulatory frameworks.
• Working knowledge of GVP and relevant global legislation.
• Familiarity with MHRA, EudraVigilance, Health Canada, FDA FAERS, and LATAM PV databases.
• Understanding of case handling/processing/submission for both clinical trials and marketed products
• Experience of periodic report preparation and review

Desirable Qualifications, Experience and Technical Skills:

• Specific post-graduate qualification in Pharmacovigilance
• Additional language
• Experience within the Service Provider (CRO) environment
• Experience of signal detection & management; safety risk management; and knowledge of the requirements for the PV System Master File
• Experience supporting post-marketing safety commitments such as FDA-mandated post-marketing studies (PMRs/PMCs).