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Pharmacovigilance Manager

Our client in the Essex area is looking for a Pharmacovigilance Manager & Deputy to the Pharmacovigilance Director to join their expanding and exciting team on a permanent basis.

Responsibilities will include supervising one full time staff member and two contract data entry professionals, taking on the responsibilities of the deputy QPPV and providing a quality tailored PV service to pharmaceutical companies in the UK and Europe.

In order to provide a high quality service for customers and to maintain good customer relations it will be essential to have a detailed knowledge of current legislation associated with the Regulatory Pharmacovigilance requirements, ensure that other members of the company are informed and trained as necessary, and maintain the PV system in line with current legislation.

This will be a customer focused role, involving the areas of business development, generation of new business, service quotes, contract negotiation and pricing.

The role will include travel to clients and potential clients both in the UK and overseas.

Professional Experience

Essentials:

�Proven experience in pharmacovigilance

�Experience of ADR processing and review

�Literature review

�Experience of PSUR writing

�SOP writing

�Experience of writing Detailed Description of Pharmacovigilance Systems (DDPS)

�Good computer skills



Preferables:

�Clinical experience

�Data processing on ARISg

�Experience of MHRA Inspections

�Experience of Medical Information

�Good training and presentation skills

�Experience of Annual Safety Reports (ASRs)

�Experience of writing Summary of Pharmacovigilance Systems (SPS)

�Experience of Risk Management Plans

�Background in both generic and innovator pharmaceutical companies

�Extensive knowledge of European Regulatory guidance

�Supervisory/managerial or team leader experience

�Experience of conducting signal generation

�Knowledge of a wide range of therapeutic areas

Personality attributes

�Confident

�Enthusiastic

�Managerial qualities

�Excellent communication skills

�Well organised and good planning abilities

�Team-based work ethic

�Good eye for detail

�Multi-tasking