Global Safety Director

hace 13 horas

Madrid, Madrid, España Teva Pharmaceuticals A tiempo completo

Teva Pharmacovigilance - A Leader in Safety Solutions

As a key member of our Medical Scientific Unit (MSU), the Director Global Pharmacovigilance will play a pivotal role in leading drug safety across our entire portfolio and product lifecycle. Collaborating with other Teva stakeholders, our MSU safety physicians and scientists will identify and define risks of our drugs, proposing measures to minimize or mitigate them. This ensures we maximize the benefit-risk ratio of our drugs and provide comprehensive safety information to patients, prescribers, and regulators.

About the Role

  • Lead the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use, and Disease Monitoring Programs.
  • Contribute to clinical documents, such as protocols, IBs, informed consent/assent forms, clinical study reports, integrated summaries of safety, CTD submissions, Regulatory Agency responses, and IRB/EC requests.
  • Lead and chair the cross-functional Product Safety Group, responsible for presenting decisions to senior governance committees and Teva's top management.
  • Perform medical review of ICSRs for assigned products from clinical trials.
  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments.
  • Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, and their management throughout the product lifecycle.
  • Represent PV on the cross-functional Product Label Working Group, leading evaluation and determination of safety-related sections of the product label, both initial and throughout the product lifecycle.
  • Guide, provide support, and train PV scientists across safety surveillance activities, such as medical review, signal detection, and risk evaluation.
  • Collaborate with various functions within and outside Teva to effectively communicate PV positions on safety concerns and the overall safety profile of assigned products.
  • Support global launch activities for assigned products.
  • Perform due diligence on product safety profiles of potential new assets.

Requirements

  • MD or equivalent degree.
  • Completion of an accredited Residency/Specialty program and Board Certification or Eligibility.
  • Minimum 5 years of experience in pharmacovigilance and drug safety as a safety physician.
  • Strong knowledge of FDA and EMA regulations (GVP, GCP).
  • Experience with NDA/BLA submissions in the US and MAA in Europe.
  • Experience in managing safety issues in pre- and post-marketing environments.
  • Proven abilities in handling safety surveillance tasks and chairing safety committee meetings.
  • Excellent communication skills in speaking and writing English.

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