Senior Director, Global Pharmacovigilance – Safety Physician (Location: UK or EU)

Job title:

Senior Director, Global Pharmacovigilance – Safety Physician (Location: UK or EU)

Company

Teva Pharmaceuticals

Job description

Who we areTogether, 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. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityTeva 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. In this way, we maximize the benefit-risk ratio of Teva drugs and provide comprehensive safety information to patients, prescribers and regulators.The locationThis role can be based in any European country, where Teva has offices/sites.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. Collaborate with other R&D teams to ensure execution of the safety strategy.
• Contribute to clinical documents, taking a lead role in safety related content (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. Be responsible to present decisions from Product Safety Group to senior governance committees and Teva’s top management.
• Performing 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 product’s life cycle.
• Represent PV on the cross functional Product Label Working Group. Lead evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development of internal CCSI
• Guide, provide support and train, as applicable, both more junior safety physicians and PV scientists across all aspects of pharmacovigilance work during clinical development including: safety surveillance activities such as; medical review, signal detection and risk evaluation activities, clinical trial risk monitoring and mitigation plans, review of statistical analysis plans, interpretation of trial safety result (TLG), drafting safety conclusions in clinical study reports, DSUR, IB etc.
• 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 we 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.

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 with experience as a safety lead
• Experience as a safety lead in both early and late stage studies including first-in-human trials
• Experience in drug development immunology or neurology therapeutic areas is a plus
• Strong knowledge of FDA and EMA regulations (GVP, GCP)
• Experience as a safety lead in a NDA/BLA submissions in the US and MAA in Europe (including contribution to briefing books, CTD dossier, response to safety LOQ/RFI, label negotiations)
• Experience in managing safety issues in pre-and post-marketing environment.
• Proven abilities on handing safety surveillance tasks in clinical trials and chairing safety committee meetings.
• Experience with mentoring junior safety physicians in a variety of PV activities
• Ability to work cross-functionally with an international team across multiple time-zones.
• Excellent communication skills in speaking and writing English.

Reports ToSr Dir MSU Team LeaderAlready Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Expected salary

Location

Harlow, Essex

Job date

Sun, 09 Feb 2025 08:27:55 GMT

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