Global Safety Director
hace 3 semanas
Teva Pharmacovigilance - A Leader in Safety Solutions
As a key member of our Medical Scientific Unit (MSU), the Director Global Pharmacovigilance will play a pivotal role in leading drug safety across our entire portfolio and product lifecycle. Collaborating with other Teva stakeholders, our MSU safety physicians and scientists will identify and define risks of our drugs, proposing measures to minimize or mitigate them. This ensures we maximize the benefit-risk ratio of our drugs and provide comprehensive safety information to patients, prescribers, and regulators.
About the Role
- Lead the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use, and Disease Monitoring Programs.
- Contribute to clinical documents, such as protocols, IBs, informed consent/assent forms, clinical study reports, integrated summaries of safety, CTD submissions, Regulatory Agency responses, and IRB/EC requests.
- Lead and chair the cross-functional Product Safety Group, responsible for presenting decisions to senior governance committees and Teva's top management.
- 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.
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, and their management throughout the product lifecycle.
- Represent PV on the cross-functional Product Label Working Group, leading evaluation and determination of safety-related sections of the product label, both initial and throughout the product lifecycle.
- Guide, provide support, and train PV scientists across safety surveillance activities, such as medical review, signal detection, and risk evaluation.
- Collaborate with various functions within and outside Teva to effectively communicate PV positions on safety concerns and the overall safety profile of assigned products.
- Support global launch activities for assigned products.
- Perform due diligence on product safety profiles of potential new assets.
Requirements
- MD or equivalent degree.
- Completion of an accredited Residency/Specialty program and Board Certification or Eligibility.
- Minimum 5 years of experience in pharmacovigilance and drug safety 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 environments.
- Proven abilities in handling safety surveillance tasks and chairing safety committee meetings.
- Excellent communication skills in speaking and writing English.
-
Pharmacovigilance Director
hace 2 días
Madrid, Madrid, España Teva A tiempo completoDirector Global Pharmacovigilance Role:As a Director of Global Pharmacovigilance, you will play a pivotal role in leading the safety profile of assigned products during clinical development. This includes Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. You will collaborate with other R&D teams to...
-
Global Safety Director
hace 4 semanas
Madrid, Madrid, España CAE Defence & Security – Indo-Pacific A tiempo completoAbout This RoleWe are seeking a highly experienced and skilled professional to lead our Global Safety Management System. As the Head of Global Safety, you will oversee the implementation of a centralized Safety Management System (SMS) to enhance safety, proactively identify hazards, and minimize risk.The ideal candidate will have previous experience...
-
Global Safety Writer
hace 2 días
Madrid, Madrid, España Baxter A tiempo completoRole OverviewWe are seeking a skilled Global Safety Writer to join our team at Baxter. As a key member of our regulatory affairs department, you will play a vital role in ensuring the safety and compliance of our pharmaceutical products worldwide.
-
Global Program Safety Lead
hace 3 semanas
Madrid, Madrid, España Novartis A tiempo completoGlobal Program Safety Lead - ImmunologyAt Novartis, we are seeking a highly skilled Global Program Safety Lead to excel as a scientific safety leader within our Immunology Medical Safety organization.About the role:Our Global Program Safety Lead will be responsible for designing and developing safety surveillance strategies for products and approvals. They...
-
Global Aviation Supply Chain Director
hace 3 semanas
Madrid, Madrid, España Dsj Global A tiempo completoGlobal Aviation Supply Chain DirectorAt Dsj Global, we are seeking a seasoned Global Aviation Supply Chain Director to lead the coordination of complex logistics operations within the aviation sector.This strategic role requires a deep understanding of end-to-end supply chain management and the ability to identify opportunities for improvement.Key...
-
Global Pharmacovigilance Director
hace 4 semanas
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoAbout the OpportunityTeva Pharmacovigilance is seeking a physician to lead the Safety physician, Director Pharmacovigilance role in the Medical Scientific Unit (MSU) to support safety in projects under development. This role will lead drug safety across the entire Teva portfolio and throughout the product lifecycle, collaborating with other Teva stakeholders...
-
Global Program Safety Lead
hace 1 mes
Madrid, Madrid, España Novartis A tiempo completoJob Description:As a Global Program Safety Lead at Novartis, you will play a critical role in designing and developing safety surveillance strategies for products and approvals. You will be responsible for overseeing the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports....
-
Director of Global Pharmacovigilance
hace 1 mes
Madrid, Madrid, España Teva Pharmaceuticals A tiempo completoUnlock the Future of Drug SafetyTeva Pharmaceuticals is seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our Medical Scientific Unit (MSU) and lead the safety profile of our products throughout the entire product lifecycle.About the RoleLead the safety profile of assigned products during clinical development, including...
-
Global Program Safety Lead
hace 4 semanas
Madrid, Madrid, España Novartis A tiempo completoJob Description:As a Global Program Safety Lead at Novartis, you will be responsible for designing and developing safety surveillance strategies for products and approvals. This includes overseeing the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. You will also be responsible...
-
Global Program Safety Lead
hace 1 mes
Madrid, Madrid, España Novartis A tiempo completoJob DescriptionAs a Global Program Safety Lead, you will be responsible for designing and developing safety surveillance strategies for products and approvals. You will oversee the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product adverse reaction reports. You will also be responsible for safety in clinical...
-
Director of Global Pharmacovigilance
hace 4 semanas
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...
-
Global REACH
hace 1 mes
Madrid, Madrid, España Rovensa A tiempo completoJob DescriptionRovensa is a global leader in sustainable solutions for agriculture, with a strong commitment to safety, empowerment, ethics, dedication, and striving. We are seeking a highly skilled Global REACH & Product Safety Expert to join our team.The successful candidate will support the development and implementation of our Global REACH & PS strategy,...
-
Global Safety Strategist for Ophthalmology
hace 4 días
Madrid, Madrid, España Regeneron A tiempo completoJob SummaryWe are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area.This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk...
-
Global Delivery Director
hace 11 horas
Madrid, Madrid, España Tekever Ltd A tiempo completoAbout UsAt Tekever Ltd, we are revolutionizing the world with cutting-edge advancements in unmanned technology. Our unique surveillance-as-a-service solution provides real-time intelligence, enhancing maritime safety and saving lives.We are looking for a skilled Global Delivery Director (Security) to join our dynamic team transforming maritime and land...
-
Director/a Global de Tesorería
hace 4 semanas
Madrid, Madrid, España Ce Consulting A tiempo completoBuscamos un/a Director/a Global de Tesorería para unirnos a nuestro equipo en Ce Consulting. Esta posición es ideal para un/a profesional experimentado/a en finanzas y tesorería que busque un desafío emocionante en una compañía líder en la aplicación de tecnología avanzada en procesos productivos.Como Director/a Global de Tesorería, serás...
-
Global Packaging Operations Director
hace 3 días
Madrid, Madrid, España Penta Consulting Limited A tiempo completoJob Title: Global Packaging Operations DirectorAbout the PositionThis is a permanent position based in Spain, Madrid.The successful candidate will be responsible for overseeing the whole packaging process ensuring our products are properly packaged according to local & international regulations as well as Customer ́s need in our Solar Sites; the ideal...
-
Automotive Safety Solutions Architect
hace 5 días
Madrid, Madrid, España Infotree Global Solutions A tiempo completoAt Infotree Global Solutions, we're seeking a talented Test Automation Engineer to shape the future of automotive safety.About UsWe're a leading innovator in the automotive industry, dedicated to enhancing road safety and saving lives. Our mission is to push the boundaries of what's possible in automotive safety technology.Job DescriptionThis role offers a...
-
Global Pharmacovigilance Director
hace 4 semanas
Madrid, Madrid, España Tevapharm A tiempo completoJob OverviewAt Tevapharm, we're committed to making good health more affordable and accessible. As a key member of our Medical Scientific Unit (MSU), you'll play a crucial role in leading drug safety across our entire portfolio and throughout the product lifecycle. In this dynamic and collaborative environment, you'll work closely with other stakeholders to...
-
Global Health and Safety Strategist
hace 5 días
Madrid, Madrid, España Coatue Management L.L.C. A tiempo completoCompany OverviewDeel, a leading international payroll and compliance platform, is dedicated to helping businesses hire top talent worldwide. With a global team of over 3,000 self-driven individuals spanning 100 countries, we're building a unified yet diverse culture that fosters innovation and excellence.Estimated Salary Range: $120,000 - $180,000 per year...
-
Global Business Director
hace 4 semanas
Madrid, Madrid, España Groupm A tiempo completoDescripción del PuestoBuscamos un/a Global Business Director para unirse a nuestro equipo global y liderar proyectos estratégicos en GroupM.El/la candidato/a ideal deberá tener experiencia comprobada en roles de liderazgo en agencias de medios, gestionando cuentas globales o regionales, idealmente con foco en Latinoamérica. Entre las responsabilidades...