- Collaborate with other R&D 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 to present decisions from the Product Safety Group to senior safety governance committees as well as other forums attended by Teva Senior management
- Perform medical reviews and assessments of ICSRs for assigned products from clinical trials
- Take accountability 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 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 products 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 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 safety surveillance activities such as: medical review, signal detection and risk evaluation activities
- Collaborate with different functions inernally (Medical Affairs, Clinical Development, Quality etc.) as well as external stakeholders (KOLs, CROs etc.) and effectively communicate the PV position on any safety concerns as well as the overall safety 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, including early and late stage development assets
- Medical Doctor / Physician or equivalent
- Completion of an accredited Residency / Specialty program - Neurology preferred
- Experience in drug development in neurology
- Proven experince working in pharmacovigilance and drug safety, as a safety physician with a significant portion of time devoted to supporting drug 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-marketing environment
- Proven ability handing safety surveillance tasks and chairing safety committee meetings
- Strong leadership capabilities and matrix management experience
- Ability to work cross-functionally with an international team across multiple time-zones
- Experience in managing safety due diligence of pharmaceuticals at varied stages 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
-
Director, Global Pharmacovigilance
hace 4 semanas
Teva Pharmaceuticals Madrid, EspañaWho 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. Wo ...
-
Senior Physician Safety Writer
hace 1 semana
Baxter Madrid, España De jornada completaVantive: A New Company Built On Our Legacy · Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people ...
-
QA Specialist
hace 1 semana
Takeda Madrid, España De jornada completaDescription · This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC) which includes ensuring that a quality management system is implemented and maintained in accordance with the Gu ...
-
Senior Proposals Associate
hace 2 semanas
PrimeVigilance Madrid, España De jornada completaJob DescriptionStrategically support and lead the development of proposals, including support strategy development and leading TCs · Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketing, operational teams, finance, ...
-
IQVIA Madrid, España De jornada completaIQVIA Safety Operations team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ...
-
Proposals Manager
hace 1 semana
PrimeVigilance Madrid, España De jornada completaJob Description · Responsibilities include: · Strategically support and lead the development of proposals, including support strategy development and leading TCs · Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketi ...
-
Gilead Sciences, S.L. Madrid, España De jornada completaDescription · Overview and key accountabilities · This role will serve as a key business partner to the Spanish Medical Affairs affiliate team and be immersed in strategic and operational analysis as well as take a lead role in driving large projects within Medical Department, ...
-
Clinical Operations and Medical Publications Specialist
hace 1 semana
Takeda Madrid, España De jornada completaDescription · JOB FUNCTION: · Primarily focused on providing technical support in activities related to the development and implementation of local Studies for the generation of data in epidemiology and Real World Evidence studies (RWE). Maintain knowledge in legislation and l ...
-
Pharmacovigilance & Patient Safety
hace 4 semanas
Michael Page Madrid, España De jornada completa¿Dónde vas a trabajar? This company is a large global player in the life science industry. With a workforce exceeding 2000 employees, the company is constantly striving to improve patient outcomes and quality of life by developing innovative pharmaceutical products. The firm is b ...
-
Senior Physician Safety Writer
hace 1 semana
Baxter Healthcare Madrid, EspañaVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we ...
-
Senior Proposals Associate
hace 1 semana
Primevigilance Madrid, EspañaWe are PrimeVigilance (part of Ergomed Group), 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: ...
-
Drug Safety Senior Specialist
hace 2 semanas
Insud Pharma, S.L.U. Madrid, EspañaDrug Safety Senior Specialist · Madrid · Madrid, Community of Madrid, ES Overview The Exeltis Pharmacovigilance team is seeking an experienced Drug Safety Senior Specialist to Manage its global operational pharmacovigilance support for the Exeltis R&D development candidates and ...
-
Drug Safety Senior Specialist
hace 3 semanas
INSUD PHARMA, S.L.U. Madrid, EspañaOverview · The Exeltis Pharmacovigilance team is seeking an experienced Drug Safety Senior Specialist to Manage its global operational pharmacovigilance support for the Exeltis R&D development candidates and marketed products. The candidate will be responsible for data review, co ...
-
Qa Specialist
hace 2 días
Takeda Madrid, EspañaBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I submi ...
-
Ww405 Director, Medical Safety Officer, Oncology
hace 4 días
Empresa reconocida Centro, España.Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located in Horsham, PA; Titusville, NJ; orRaritan, NJ. At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex d ...
-
Senior Specialist, Quality Assurance Auditor
hace 3 semanas
bioM?rieux BV Comunidad de Madrid, EspañaJob Description · The Position · The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in ...
-
Medical Operations Manager
hace 3 semanas
Ascendis Pharma Madrid, EspañaAre you passionate about changing the lives of people living with rare diseases? · Do you have experience within Medical Affairs? · If so, now is your chance to join Ascendis Pharma Iberia as our new Medical Operations Manager in Madrid, Spain. · Ascendis Pharma is a fast-growin ...
-
Clinical Operations And Medical Publications Specialist
hace 2 semanas
Takeda Madrid, EspañaClinical Operations and Medical Publications Specialist · Madrid · Madrid, Community of Madrid, ES By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processe ...
-
Director of Clinical Development
hace 1 semana
Recordati Centro, EspañaTerritory: · Shift: Full Time · Seniority: Director · With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. · We are a group of like-minded ...
-
Director Of Clinical Development
hace 1 semana
Recordati Madrid, EspañaTerritory: · Shift: Full Time · Seniority: Director · With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. · We are a group of like-minded ...
Director, Global Pharmacovigilance - Madrid, España - Teva Pharmaceuticals
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Descripción
The opportunity
As 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
Your experience and qualifications