Senior Director, Global Pharmacovigilance - Safety Physician (Location: UK or EU)
Date: Feb 15, 2025
Location: Harlow, United Kingdom, 28108
Job Id: 60086
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.
The opportunity
Teva Pharmacovigilance unit is hiring a physician for the Safety physician, Senior Director Pharmacovigilance role to join the Medical Scientific Unit (MSU) and support safety in projects under development. In this unit we lead drug safety across the entire Teva portfolio and throughout the product lifecycle. In partnership with other Teva stakeholders, our MSU safety physicians and scientists identify and define the risks of our drugs and propose measures to minimize or mitigate them.
How you’ll spend your day
* Lead the safety strategy of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs.
* Contribute to clinical documents, taking a lead role in safety related content.
* Lead and chair the cross functional Product Safety Group.
* Perform medical review of 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 PV on the cross functional Product Label Working Group.
* Guide, provide support and train junior safety physicians and PV scientists.
* 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.
Your experience and qualifications
* MD or equivalent.
* Completion of an accredited Residency/ Specialty program and is Board Certified or Eligible.
* 8 year minimum working in pharmacovigilance and drug safety area as a safety physician.
* Experience as a safety lead in both early and late stage studies.
* Strong knowledge of FDA and EMA regulations.
* Experience as a safety lead in 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 in clinical trials.
* Ability to work cross-functionally with an international team across multiple time-zones.
* Excellent communication skills in speaking and writing English.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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