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Director, Head of Pharmacovigilance

Director, Head of Pharmacovigilance

Job Title: Director, Head of Pharmacovigilance
Contract Type: Contract
Location: Berkshire
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: PVD1
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: December 22, 2016 08:46

Job Description

Mission:

  • Develop and lead all pharmacovigilance (PV) activities within the business for Clinical Development programs and Commercial products.

Main responsibilities:

  1. Lead the PV team and develop PV organization capabilities.
  2. Manage external PV vendors (CROs), ensuring service quality and cost-effectiveness. Balance internal resources and outsourcing in alignment with the company needs and business model.
  3. Monitor the relationship with commercial partner(s) regarding joint PV activities.
  4. Organize and monitor the processing and medical review of Individual Case Safety Reports (ICRs) for our compounds in clinical development and post-marketing. Discuss the ICSRs with the Project Medical Directors and ensure the timely reporting to the Authorities / clinical sites / partners.
  5. Evaluate the safety profile of our compounds: in collaboration with the different company experts and/or partners/vendors, evaluate and update the risk-benefit profile of our compounds (post-marketing and in development), write periodic safety reports (Development Safety Update Reports (DSURs), Periodic Safety Update reports (PSURs).
  6. Manage the signal detection activities and risk management plan for the different compounds. Perform signal evaluation & validation.
  7. Manage PV activities according to the existing Safety Data Exchange Agreements (SDEAs). Update the SDEAs if necessary.
  8. Secure the maintenance and the accuracy of the PV database
  9. Report regularly pharmacovigilance activities to the VP of the Clinical Research & Development Department and to the Project/Clinical Study Teams. Be the link with Research & Manufacturing.
  10. Review and Maintain the Standard Operating Procedures (SOPs) / Operating Instructions (OIs) / Pharmacovigilance System Master File (PSMF) up to date.
  11. Maintain up to date expertise in pharmacovigilance and develop the expertise of the PV team.
  12. Organize the participation of a PV member in the Project teams / Clinical Study teams according to the request of Project / Study team manager.
  13. Participate in the Clinical Study Protocol & Investigator Drug Brochure writing/review with regards to PV matters.
  14. Promote the pharmacovigilance within the project/study teams and within the company

Profile required:

  1. MD with at least 10 years of experience in Pharmaceutical industry
  2. Minimum 5 years of Managerial experience in Pharmacovigilance
  3. Proven track record managing service providers such as CROs and working with in-and out-licensees
  4. Experienced in writing safety reports, risk management plans and other safety documents
  5. Able to work closely with Clinical Development teams
  6. Experienced in setting up PV processes and building organization capabilities
  7. Excellent knowledge of pharmacovigilance and regulatory procedures (Swiss, Europe and USA)
  8. Good communication and negotiation skills
  9. Ability to work and influence within a matrix organization
  10. Attention to detail