Medical Safety Physician (Director)

Job Type: permanent
Job Category: PVG and Drug Safety
Posted: 19th August 2021

My client a leading Pharmaceutical Company are currently looking for an experienced Pharmacovigilance Physician to join their diverse, collaborative and inclusive Safety Team. You will be integral in the continued establishment and development of the safety function of the business as they continue to grow. You will lead safety profile oversight for all assigned products, across their full life cycle whilst working cross functionally to ensure the needs of this dynamic and fast-moving business are met. This is a position with both a hands on and a strategic focus. If you are an experienced Pharmacovigilance Physician, please read below…

 

Responsibilities;

  • Performance of medical review of AE’s for assigned products alongside ongoing surveillance of safety data from various sources
  • Implementation of risk mitigation activities, preparation of benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds
  • Performance of medical review and provide safety input to for various documents e.g. trial protocols and amendments, clinical trial reports, trial plans, eCRFs/CRFs, TMFs,IBs, Subject Informed Consent, DSURs, Integrated Safety Summaries, scientific articles, etc.
  • Active involvement in for establishing and managing external data monitoring
  • committees (DMCs)
  • Participate and/or run safety committees for assigned products
  • Conduct safety training of colleagues, CROs and investigators
  • Contribute to multidisciplinary project groups and provide input to clinical development programs
  • Performance of sponsor oversight, collaborate with external experts and partners, contribute to multidisciplinary project groups
  • Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections, participate in audit and inspection activities as relevant

Requirements;

  • Medical Degree (MD) required
  • Clinical research and/or fellowship training in oncology, onco-haematology, internal, cardiometabolic diseases, autoimmune diseases, pharmacology or other relevant specialty is a plus
  • Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP).
  • Exposure to working relationship with EMA/Swissmedic/MHRA and other regulatory authorities (FDA) is preferred
  • Strong knowledge of individual adverse event case report processing, triage and medical review
  • Working knowledge of safety databases and electronic data capture systems
  • Working experience with PV audit process with active participation in Regulatory Authority Inspections
  • Excellent knowledge of drug development process
  • Excellent written and oral communication skills

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