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Job Details

Associate Director, Senior PV Physician, Deputy EUQPPV

Company: Advanced Clinical Recruitment Ltd
Location:
Reference: Associate Director - Semior PV, Dp. EUQPPV
Closing Date: 24 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

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 jcoomey@acr-uk.com LinkedIn Search: Josh Coomey - Global Medical & Clinical Development

Requirements:

Main Purpose


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.

 

Main Tasks:

  • ? Coordinate, manage and oversee the production of RMPs to ensure they are produced in line with company SOPs, quality standards and timelines
  • ? Oversight of the review and medical assessment of ICSRs, periodic safety reports, risk management plans and reflection of emergent safety data in product labelling
  • ? Provide expertise and support for urgent safety reviews and competent authority RFIs for products including issues relating to product quality
  • ? Provide input into the creation and maintenance of pharmacovigilance processes and procedures, documented in company Standard Operating Procedures, Guidelines and User Manuals. Contribute to their effective implementation through targeted training activities
  • ? Support regulatory inspection and internal quality audits by contributing to inspection preparedness and acting as subject matter expert for defined PV processes.
  • Provide leadership and oversee training and development of junior PV physicians and other GPV staff.
  • Support affiliates and PV responsible staff in delivery of local pharmacovigilance activities.
  • Provide PV support for due diligence and other business development opportunities & integration as required.

Relationships:

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:

  • ? Medical qualification and UK Registration or equivalent. Further qualification in pharmaceutical medicine preferred, but not essential.
  • ? Significant experience in pharmaceutical/biotech industry or CRO with specific experience of pharmacovigilance activities as above.
  • ? Good knowledge of relevant global pharmacovigilance and device requirements for post marketing and development product safety.
  • ? Excellent knowledge of the European regulatory environment for both pre- and post-marketing product safety.
  • ? Sufficient experience in PV systems to ensure the integrity of the businesses systems, particularly in the areas of risk management and signal detection.
  • ? Experience in clinical development safety and previous experience of supporting QPPV responsibilities advantageous.
  • ? Previous management/ leadership experience desirable.
  • ? Knowledge and skills should be maintained by appropriate continuing professional development activities.

Apply for this job: Associate Director, Senior PV Physician, Deputy EUQPPV

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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