Company: Advanced Clinical Recruitment Ltd
Reference: Associate Director - Semior PV, Dp. EUQPPV
Closing Date: 24 Dec 16
Salary (£): Competitive
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest! Josh Coomey - Advanced Clinical Recruitment +44 (0) 114 2945005 firstname.lastname@example.org LinkedIn Search: Josh Coomey - Global Medical & Clinical Development
To support the GPV Medical Director & QPPV in the effective delivery of Pharmacovigilance & Device Vigilance activities for all the businesess products (both commercialised and under development) in order to meet worldwide regulatory requirements, company objectives and quality standards within Norgine. The incumbent will be required to perform duties of Deputy QPPV and deputise for the GPV Medical Director as required. Line management of junior PV Physician and Benefit Risk scientist, support for operational GPV staff, including PV service providers for outsourced activities.
Key Responcibilities and Accountabilities:
Provide leadership and, in collaboration with GPV Lead Team, take responsibility for maintaining efficient and compliant operational drug and device safety processes and systems throughout the business, meeting applicable global legal and regulatory requirements. .
Accountable for the benefit risk product profiles of delegated company products, both pre and post marketing, including signal detection, evaluation, benefit risk review of aggregate safety reports, Risk Management Plans, product safety labelling and implementation of resulting PV recommendations, authoring of expert advice and statements & oversight of those undertaken by members of staff in training.
Liaise with other departments (Commercial, Therapy Area Teams, Business Development, Medical and Regulatory Affairs) to support risk management planning and institute appropriate post-authorisation safety and efficacy studies.
Skills and Knoledge:
Regus 2nd Floor
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