Director Global Pharmacovigilance - Safety Physician
Date: Jan 17, 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. The opportunity
Teva Pharmacovigilance unit is hiring a physician for the Safety physician, 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. How you’ll spend your day
Lead the safety profile 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, (e.g. protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety related clinical documents). 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 and contribute to the preparation of Risk Management Plans (RMPs). Represent PV on the cross functional Product Label Working Group. Guide, provide support and train, as applicable, PV scientists across safety surveillance activities. Collaborate with different functions both in Teva and outside Teva to effectively communicate PV position on any safety concerns. 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. 5 year minimum working in pharmacovigilance and drug safety area as a safety physician. Experience in drug development immunology or neurology therapeutic areas is a plus. 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 handing safety surveillance tasks and chairing safety committee meetings. 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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Date: Jan 17, 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. The opportunity
Teva Pharmacovigilance unit is hiring a physician for the Safety physician, 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. How you’ll spend your day
Lead the safety profile 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, (e.g. protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety related clinical documents). 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 and contribute to the preparation of Risk Management Plans (RMPs). Represent PV on the cross functional Product Label Working Group. Guide, provide support and train, as applicable, PV scientists across safety surveillance activities. Collaborate with different functions both in Teva and outside Teva to effectively communicate PV position on any safety concerns. 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. 5 year minimum working in pharmacovigilance and drug safety area as a safety physician. Experience in drug development immunology or neurology therapeutic areas is a plus. 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 handing safety surveillance tasks and chairing safety committee meetings. 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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