Director Global Pharmacovigilance
hace 1 mes
Date: Sep 23, 2024
Location: Madrid, Spain, 28108
Job Id: 58386
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.
The opportunityTeva 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. 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.
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.
- 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.
- 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.
- 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.
- Ability to work cross-functionally with an international team across multiple time-zones.
- Excellent communication skills in speaking and writing English.
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.
#J-18808-Ljbffr-
Director Global Pharmacovigilance
hace 3 meses
Madrid, España Tevapharm A tiempo completo.Director Global Pharmacovigilance - Safety PhysicianDate: Sep 23, 2024Location: Madrid, Spain, 28108Job Id: 58386Together, 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...
-
Manager, Global Pharmacovigilance, Patient
hace 3 días
Madrid, España Kyowa Kirin International A tiempo completoOverview: At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients,...
-
Madrid, Madrid, España Empresa Reconocida A tiempo completoJob DescriptionWe are seeking a highly skilled Global Safety and Pharmacovigilance Delivery Director to join our team at Empresa Reconocida in Bangkok, Thailand.About the RoleThis is an exceptional opportunity for a seasoned professional to lead our safety and pharmacovigilance projects, working closely with clients and internal stakeholders to deliver...
-
Medical Director for Pharmacovigilance Leadership
hace 3 semanas
Madrid, Madrid, España Parexel A tiempo completoCompany OverviewParexel is a leading biopharmaceutical services company dedicated to improving global health. We provide a comprehensive suite of services that enable our clients to transform scientific discoveries into new treatments. Our team is committed to upholding the highest standards of quality, respect, and accountability.About the RoleWe are...
-
Global Pharmacovigilance Lead
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoUnlock a world of possibilities in pharmacovigilance with Teva Pharmaceuticals. As a physician, you will lead the safety profile of assigned products during clinical development, ensuring compliance with regulatory requirements and contributing to the submission of Common Technical Documents (CTD). Your expertise will be invaluable in leading...
-
Global Pharmacovigilance Specialist
hace 3 semanas
Madrid, Madrid, España Ergomed A tiempo completoAbout PrimeVigilancePrimeVigilance, a leading pharmacovigilance service provider, offers exciting opportunities for skilled professionals. We are part of Ergomed Group, a specialized mid-size company established in 2008.Job DescriptionWe are looking for a highly motivated Global Pharmacovigilance Specialist to join our team. As a PV Officer, you will work...
-
Pharmacovigilance Specialist
hace 4 semanas
Madrid, Madrid, España Ergomed Group A tiempo completoCompany OverviewErgomed Group is a global provider of high-quality specialist services in clinical development, pharmacovigilance, and medical imaging.
-
Pharmacovigilance Associate
hace 7 meses
Madrid, España BAXTER A tiempo completo**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Global Pharmacovigilance Director
hace 3 semanas
Madrid, Madrid, España Tevapharm A tiempo completoCompany OverviewTevapharm is a leading manufacturer of generic medicines, committed to making good health more affordable and accessible worldwide. With operations in nearly 60 countries and a rich diversity of nationalities and backgrounds, we strive for excellence in every aspect of our business.The OpportunityWe are seeking an experienced Safety Physician...
-
Jr. Pharmacovigilance Specialist
hace 2 días
Madrid, España Biomapas A tiempo completoJoin our Pharmacovigilance team as a Junior Pharmacovigilance Specialist in Spain.Jr. Pharmacovigilance Specialist is responsible for assuring compliance with local and regional Quality Management System and interact, exchange relevant safety and pharmacovigilance information.All CVs must be submitted in the English language for consideration.Benefits of...
-
Pharmacovigilance Technician
hace 2 semanas
Madrid, España Empresa Reconocida A tiempo completo.1750 Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via:Access - Providing high quality trusted medicines...
-
Pharmacovigilance Technician
hace 2 semanas
Madrid, España Empresa Reconocida A tiempo completo.1750 Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines...
-
Senior Medical Director
hace 4 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Senior Medical Director
hace 1 mes
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.From clinical trials to regulatory, consulting, and market access, our therapeutic,...
-
Pharmacovigilance Specialist
hace 3 semanas
Madrid, Madrid, España Prime Vigilance Ltd A tiempo completoCompany Overview: PrimeVigilance Ltd is a leading provider of pharmacovigilance services, established in 2008. With a strong presence in Europe, North America, and Asia, we offer comprehensive support to pharmaceutical and biotechnology companies.About the Role: We are seeking a Senior Pharmacovigilance Associate to join our team. As a key member of our...
-
Pharmacovigilance Specialist
hace 7 días
Madrid, Madrid, España Prime Vigilance A tiempo completoWe are PrimeVigilance, a leading provider of pharmacovigilance services established in 2008. Our global presence, with staff based across Europe, North America, and Asia, enables us to deliver high-quality support to pharmaceutical and biotechnology partners worldwide.Our MissionWe aim to provide exceptional service by maintaining long-lasting relationships...
-
Project Director
hace 6 meses
Madrid, España PrimeVigilance A tiempo completo**Company Description** Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility...
-
Global Pharmacovigilance Specialist
hace 3 semanas
Madrid, Madrid, España Prime Vigilance Ltd A tiempo completoOverviewPrimeVigilance Ltd is seeking a highly skilled PV Officer to join our team. As a key member of our case processing team, you will be responsible for managing Individual Case Safety Reports (ICSRs) from various sources, including post-marketing and clinical trials. Your primary goal will be to ensure compliance with applicable regulations,...
-
Pharmacovigilance Case Processing Specialist
hace 3 semanas
Madrid, Madrid, España Ergomed A tiempo completoWe are Ergomed, a specialist pharmacovigilance service provider, and we're seeking a skilled Pharmacovigilance Case Processing Specialist.About UsAs a leading player in the field, we've achieved global organic growth year after year. Our team members are based across Europe, North America, and Asia, providing exceptional support to our pharmaceutical and...
-
Senior Pharmacovigilance Associate
hace 3 semanas
Madrid, España Prime Vigilance Ltd A tiempo completo.We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...