Director, Global Pharmacovigilance
hace 3 semanas
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Director, Global Pharmacovigilance - Neurology Safety Physician (Location: EU or UK)Date: May 24, 2024
Location:
Madrid, Spain, 28108
Job Id: 50597
Who are we?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.
This role can be based in any EU country or the UK, where Teva has offices/sites.
The opportunityAs a Director, Global Pharmacovigilance - Neurology Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle.
You will lead activities necessary to determine the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and post marketing, including Company / Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs.
How you'll spend your day- Collaborate with other R&D teams to ensure execution of the safetystrategy
- Contribute to clinical documents, (e.g. study protocol, IB, informed consent/assentform, clinical study report, integrated summaries of safety, Common TechnicalDocument (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 to presentdecisions from the Product Safety Group to senior safety governance committees aswell as other forums attended by Teva Senior management
- Performmedical reviews and assessments of ICSRs for assigned products fromclinical trials
- Take accountability for medical evaluation/interpretation of aggregate safety data ofassigned products, including signal detection and evaluation, dose escalationevaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safetyreview/assessments of assigned and other products
- Lead risk management activities for assigned products globally and contribute to thepreparation of Risk Management Plans (RMPs), REMS, as well as management ofthese plans throughout productslife cycle
- Represent PV on the cross functional Product Label Working Group. Lead evaluationand determination of safety related sections of the product label, both initial andthroughout the product life cycle. Act as a key member for safety related label negotiations with regulatory agencies as well as in the development of internal CCSI
- Provide PV support and contribution to MAA/NDA/BLA submissions
- Guide, provide support and train PV scientists across safetysurveillance activities such as: medical review, signal detection and risk evaluationactivities
- Collaborate with different functionsinernally (Medical Affairs, ClinicalDevelopment, Quality etc.) as well as external stakeholders (KOLs, CROs etc.) and effectively communicate the PV position on any safety concerns as well as the overallsafety profile of assigned products
- Support global launch activities for assigned products
- Perform Signal detection / management related activities including PM AE review,literature review and Health Hazard Assessments as relevant. Perform due diligence on product safety profile of potential new assets, includingearly and late stage development assets
- Completion of an accredited Residency / Specialty program - Neurology preferred
- Proven experince working in pharmacovigilance and drug safety, as asafety physician with a significant portion of time devoted to supportingdrug development activities (Phase 1 – 3)
- 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-marketingenvironment
- Proven ability handing safety surveillance tasks and chairing safetycommittee meetings
- Strong leadership capabilities and matrix management experience
- Ability to work cross-functionally with an international team acrossmultiple time-zones
- Experience in managing safety due diligence of pharmaceuticals at variedstages of development
- Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority (this role comes with no direct line management responsibility)
- Oral and written fluency in English
Senior Director, MSU Team Leader (based in Israel)
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
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.
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Director, Global Pharmacovigilance
hace 3 semanas
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoThe opportunityAs a Director, Global Pharmacovigilance - Neurology Safety Physician you will be part of the Global Pharmacovigilance (PV) and Medical Scientific Unit (MSU) supporting drug safety across the entire Teva portfolio and throughout the product lifecycle. You will lead activities necessary to determine the safety profile and the characterization,...
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