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Director of Regulatory, Pharmacovigilance and Medical

Pharmaceutical Generics

North Devon

Permanent

Updated March 30, 2012

Actavis develops, manufactures, and sells first-class generic pharmaceuticals and has one of the broadest product portfolios and pipelines in the industry. With facilities across the globe, and part of a successful wider group, they currently employ a diverse workforce of around 10,000 people. The UK is entering a period of exciting growth and investment, and the organisation aims to be an attractive employer in all markets where it conducts its business operations.

Actavis are proud of their recognition and accreditation within the "Best Companies" category and have recently received an industry Pharmaceutical Award for"Innovation in Generics", for the third year running. It is an exciting time to join the team at Actavis.

We are therefore delighted to be engaged in their search for a talented Director of Regulatory, Pharmacovigilance and Medical who will lead and direct their pharmacovigilance (PV) and regulatory activity.

Your main responsibilities will include:

• Evolving a strategic and pro-active departmental function ensuring market information drives appropriate commercial decision making
• Undertaking the lead role in regulatory authority inspections and internal audits, working closely with relevant UK and European teams in preparation and hosting activities, developing and implementing corrective action plans associated with audits/inspections
• Ensuring robust procedures for the collection of safety data in the UK and its transfer to the central pharmacovigilance (PV) function in Europe, including defined acknowledgment and reconciliation procedures.
• Negotiation and supervision of contracts with the providers of the outsourced Medical Information function (the provider also performs some pharmacovigilance (PV) activities)
• Monitoring key internal and external pharmacovigilance (PV) compliance indicators and highlighting issues to the QPPV and MAH management as necessary
• Ensuring that all safety-related queries arising from the MHRA are notified to the EU QPPV and that a high quality response is prepared and submitted in a timely fashion

Who we're looking for
The successful candidate will be an accomplished pharmacovigilance (PV)expert with a combination of strong PV understanding and sophisticated commercial awareness. Experience of working in a changing or rapidly evolving company will be vital, as will be the experience of having worked in a dynamic international pharmaceutical business.
Ideally we are looking for the following qualifications and experience;

Must be a life-science graduate, preferably with a postgraduate qualification, possibly a medical degree or a previous healthcare professional
• Membership of relevant professional bodies (e.g. PIPA, Regulatory Affairs Association, BrAPP)
• Pharmacovigilance (PV) professional with at demonstrable experience in the pharmaceutical industry with excellent knowledge of recent pharmacovigilance (PV) legislation.
• A good knowledge of ABPI Code of Practice, the UK health system and UK customer base would be desirable
• Proven managerial experience (i.e. decision making and problem solving, people management & budgetary responsibility)
Excellent communication, interpersonal and leadership skills
• Strong motivational skills with the ability to coach and mentor personnel

About our client
World leading generics pharmacovigilance (PV)organisation Actavis, accredited "Best Companies" to work for

What's on offer
Competitive package and corporate benefits, negotiable. Relocation package

Michael Page Contact
For further info, apply or phone on 0113 388 9000. Job Ref: 13194862
Your application will be sent to Emma Whittle.

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