Director of Global Pharmacovigilance

hace 3 semanas

Madrid, Madrid, España Tevapharm A tiempo completo
Job Title: Director Global Pharmacovigilance

At Teva Pharmaceuticals, we are committed to making good health more affordable and accessible. As a Director of Global Pharmacovigilance, you will play a critical role in ensuring the safety of our products and protecting the health of our customers.

About the Role

We are seeking a highly skilled and experienced Safety Physician to lead our Pharmacovigilance unit. As a key member of our Medical Scientific Unit (MSU), you will be responsible for identifying and defining the risks of our drugs and proposing measures to minimize or mitigate them.

Key Responsibilities
  • 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, informed consent forms, clinical study reports, and Common Technical Document (CTD) submissions.
  • Perform medical review of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned products.
  • Lead risk management activities for assigned products globally.
  • Represent Pharmacovigilance on the cross-functional Product Label Working Group.
  • Guide, provide support, and train PV scientists across safety surveillance activities.
  • Collaborate with different functions both in Teva and outside Teva.
  • Support global launch activities for assigned products.
  • Perform due diligence on product safety profile of potential new assets.
Requirements

We are looking for a candidate with a strong background in pharmacovigilance and drug safety. The ideal candidate will have:

  • MD or equivalent degree.
  • Completion of an accredited Residency/Specialty program and is Board Certified or Eligible.
  • 5 years minimum working in pharmacovigilance and drug safety area 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 environment.
  • Proven abilities on handling safety surveillance tasks.
  • Ability to work cross-functionally with an international team across multiple time-zones.
  • Excellent communication skills in speaking and writing English.
What We Offer

Teva Pharmaceuticals is committed to equal opportunity in employment. We are an equal opportunity employer and welcome applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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