Safety Physician Director

4 hours ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
About the Role

Teva Pharmaceuticals is seeking a highly skilled and experienced Safety Physician Director to join our Medical Scientific Unit (MSU). As a key member of our team, you will play a critical role in ensuring the safety of our innovative products throughout their lifecycle.

Key Responsibilities
  • Lead activities necessary for the determination of the safety profile and characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing.
  • Collaborate with other R&D/cross-functional teams to ensure execution of the safety strategy.
  • Contribute to clinical documents, including study protocols, informed consent forms, and regulatory submissions.
  • Lead and chair cross-functional Product Safety Groups and present decisions to senior safety governance committees.
  • Perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products.
  • Accountable for medical evaluation/interpretation of aggregate safety data, including signal detection and evaluation.
  • Perform signal management activities, including signal validation, QC, and authoring of complex signal evaluations.
  • Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs).
  • Represent PV in cross-functional Product Label Working Groups and lead evaluation and determination of safety-related sections of the product label.
  • Provide PV support and safety contributions to Health Authority submissions and responses.
  • Collaborate with different functional stakeholders in Teva and outside Teva effectively representing PV position on any safety concerns.
Requirements
  • MD degree or equivalent.
  • General practitioner license; certification/background in neurology is a plus.
  • 3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician.
  • Experience in managing safety issues in pre- or post-marketing environment.
  • Strong knowledge of FDA and EMA regulations (GVP, GCP).
  • Experience with NDA/BLA submissions in the US and MAA in Europe is a plus.
  • Ability to work cross-functionally with an international team across multiple time-zones.
  • Excellent communication skills in speaking and writing English.

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