Key responsibilities: The Pharmacovigilance Medical Director is a key position in the execution of safety strategies to ensure successful development for new drug entities globally. Leading Safety functions globally you will help to develop safety strategies, ensuring patient safety and regulatory compliance including for products that are in development and already marketed. You will also provide medical input to meet international regulatory requirements and company objectives. At times you will need to support the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the company’s PV System. Other responsibilities include: Leading the preparation of Risk Assessments for company products, leading signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment report and support of other similar reports and actions. In addition you will need to contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of company products, safety issue works up etc. Also given the seniority of the position, external engagements are regular with KOL’s and regulatory bodies so it is highly important to maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department. Often you may need to meet with regulatory bodies or be subject to questioning/audits so the ability to communicate affective, present and build relationships with key external stakeholders is key.
Previous roles/experience would include:Pharmacovigilance Physician, Drug Safety Physician, Associate Director – Pharmacovigilance, Safety Lead, Local Safety Officer
Usually reports into:Vice President of Pharmacovigilance, Senior Medical Director Pharmacovigilance, CMO, CSO
Sits within this team:QPPV, Deputy QPPV, Pharmacovigilance Physician, Drug Safety Physician, Associate Director – Pharmacovigilance, Safety Lead, Local Safety Officer, Drug Safety Associate, Drug Safety Officer, Pharmacovigilance Manager
Qualifications:Medical Degree, MD, MBBS, MBChB, GMC Registration (UK).
Salary band:£110,000 - £180,000 Basic Salary, Bonus, Car Allowance, Long Term Incentives, Share Options, Pension, Private Medical Care, Dental Care