Director of Global Pharmacovigilance
hace 2 semanas
At Teva Pharmaceutical Industries, we are committed to making good health more affordable and accessible. We are seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our team.
Job Summary:The Director of Global Pharmacovigilance will be responsible for leading the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. This role will also involve collaborating with other R&D teams to ensure execution of the safety strategy.
Key Responsibilities:- Lead the safety profile of assigned products during clinical development
- Collaborate with other R&D teams to ensure execution of the safety strategy
- Contribute to clinical documents, including 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, including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other products
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans throughout the product lifecycle
- Represent PV on the cross-functional Product Label Working Group
- Guide, provide support and train, as applicable, PV scientists across safety surveillance activities such as medical review, signal detection and risk evaluation activities
- Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, Quality etc.) and outside Teva (KOLs CROs etc.) to effectively communicate PV position on any safety concerns as well as the overall safety profile of assigned products
- Support global launch activities for assigned products
- Perform due diligence on product safety profile of potential new assets
- 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 handling 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
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Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoJob Title: Director Global PharmacovigilanceAt 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 RoleWe are seeking a highly skilled and experienced...
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Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoJob Title: Director Global PharmacovigilanceAt 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 RoleWe are seeking a highly skilled and experienced...
-
Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoJob Title: Director Global PharmacovigilanceWe are seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our team at Teva Pharmaceuticals. As a key member of our Medical Scientific Unit (MSU), you will play a critical role in leading the safety profile of our products during clinical development and post-marketing phases.Key...
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Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoJob Title: Director Global PharmacovigilanceWe are seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our team at Teva Pharmaceuticals. As a key member of our Medical Scientific Unit (MSU), you will play a critical role in leading the safety profile of our products during clinical development and post-marketing phases.Key...
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Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoThe OpportunityTeva Pharmaceuticals is seeking a highly skilled and experienced physician to lead our Pharmacovigilance unit as a Director of Global Pharmacovigilance. In this role, you will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical development to post-marketing surveillance.About the RoleLead the safety...
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Director of Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoThe OpportunityTeva Pharmaceuticals is seeking a highly skilled and experienced physician to lead our Pharmacovigilance unit as a Director of Global Pharmacovigilance. In this role, you will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical development to post-marketing surveillance.About the RoleLead the safety...
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Director of Global Pharmacovigilance
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Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoThe OpportunityTeva Pharmaceuticals is seeking a highly skilled and experienced physician to join our Pharmacovigilance unit as a Director of Global Pharmacovigilance. In this role, you will be responsible for leading the safety profile of assigned products during clinical development, collaborating with other R&D teams to ensure execution of the safety...
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Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoAbout the RoleTeva Pharmaceuticals is seeking a highly skilled physician to lead the safety profile of our products during clinical development. As a Director of Global Pharmacovigilance, you will collaborate with cross-functional teams to ensure the execution of our safety strategy.Key ResponsibilitiesLead the safety profile of assigned products during...
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