Job Information
Teva Pharmaceuticals Associate Director Pharmacovigilance - Safety Physician (Location: Europe or UK) in Bucharest, Romania
Associate Director Pharmacovigilance - Safety Physician (Location: Europe or UK)
Date: Apr 25, 2024
Location:
Bucharest, Romania, 050713
Company: Teva Pharmaceuticals
Job Id: 54975
Who we are
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. 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.
Role location
This role can be based in any European country or the UK, where Teva have offices/sites.
The opportunity
Teva Pharmacovigilance unit is hiring a physician for the Safety Physician, Associate Director Pharmacovigilance role to join the Medical Scientific Unit (MSU) and support safety in Teva’s innovative products in pre- and post-marketing environment. In the MSU, we lead drug safety across the entire Teva portfolio and throughout various stages in the product lifecycle. In partnership with other Teva stakeholders, our MSU safety physicians identify and define the risks of Teva’s drugs and propose measures to monitor, 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.
How you’ll spend your day
Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post marketing including, as applicable, company sponsored studies, investigator sponsored studies, compassionate use, and disease monitoring programs. Collaborate with other R&D/cross-functional teams to ensure execution of the safety strategy.
Contribute to clinical documents (e.g., study 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, DMC charters, Medical Monitoring Plans, Statistical Analysis Plans, and other relevant safety related clinical documents).
Lead and chair the cross-functional Product Safety Group. Be responsible for presenting decisions from Product Safety Group to senior safety governance committees as well as other forums attended by Teva’s senior management.
Perform medical review and assessment of ICSRs for assigned products from clinical trials.
Being accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety reviews/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
Represent PV in 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 and maintenance of CCSI.
Provide PV support and safety contributions to Health Authority submissions (MAA/NDA/BLA submissions) and responses. Support global launch activities for assigned products.
Collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.) as well as outside Teva (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products.
Guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities such as medical review, signal detection, and risk evaluation activities.
Perform due diligence on product safety profile of potential new assets.
Your experience and qualifications
MD degree or equivalent
General practitioner license; certification/background in neurology is a plus
3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician with
Experience in managing safety issues in pre- or post-marketing environment.
Proven abilities on handing safety surveillance tasks and chairing safety committee meetings.
Experience in drug development is a plus
Strong knowledge of FDA and EMA regulations (GVP, GCP)
Experience with NDA/BLA submissions in the US and MAA in Europe is a plus
Experience in managing safety due diligence of pharmaceuticals is a plus
Ability to work cross-functionally with an international team across multiple time-zones.
Excellent communication skills in speaking and writing English.
Reports To
MSU Team Leader (based in USA)
Already 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:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
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 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, colour, 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.
EOE including disability/veteran