- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Join Takeda as an Executive Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic Area… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- … Director , Patient Safety Risk Management. Under the guidance of the Executive Director of Kite Safety & Pharmacovigilance (PV), you are responsible for ... of postmarketing safety and real-world evidence with other activities within pharmacovigilance and patient safety. **Key Accountabilities:** + Liaises with the… more
- Ascendis Pharma (Palo Alto, CA)
- …join Ascendis Pharma as our new Technical Business Analyst for the Pharmacovigilance IT team. Ascendis Pharma is a fast-growing biopharmaceutical company with ... you will play a crucial role in digitalizing our pharmacovigilance team as we embark on an ambitions journey...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and interpersonal… more
- AbbVie (Chicago, IL)
- …(https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn. Job Description The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient ... Safety leads the scientific strategy for pharmacoepidemiology and real-world evidence to support product development and safety across therapeutic areas. They design and interpret studies, contribute to regulatory submissions, and provide expertise in… more
- AbbVie (North Chicago, IL)
- …added to our talent pipeline and considered for future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the ... scientific strategy for pharmacoepidemiology and real-world evidence to support product development and safety across therapeutic areas. They will design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. Associate Director , Medical Safety Science reports to Head of Global Medical Safety Science. ... Assists Head of Global Medical Safety Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and… more
- Taiho Oncology (Princeton, NJ)
- Sr. Director , PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July 15, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... a transformative journey with Taiho Oncology as a Sr. Director , PV Medical Surveillance . At the forefront of..., PV Medical Surveillance . At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment… more
- United Therapeutics (Columbus, OH)
- …other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case ... role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation,… more
- AbbVie (Jersey City, NJ)
- …detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology ... pharmacy, clinical development, and discovery + Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with… more
- ThermoFisher Scientific (Wilmington, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years) Medical Director level requires: + Clinical ... REMS, RMP and CSR). **General Support:** Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines… more
- Merck (West Point, PA)
- …will be responsible for managing the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring ... PV strategies: Work with cross-functional teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety,… more
- ThermoFisher Scientific (Greenville, NC)
- …instructions, forms, templates) + Support adverse event reporting training and pharmacovigilance awareness activities cross functionally + Support the preparation of ... pharmacovigilance agreements with clinical development or commercial business partners...the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance /drug safety (global experience is a plus) + At… more
- AbbVie (North Chicago, IL)
- …detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities + ... -device combined products + Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual...experience in PV required - 10+ years of Drug Safety/ Pharmacovigilance experience, including both investigational and marketed products required… more
- Gilead Sciences, Inc. (Foster City, CA)
- …teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical review of individual case ... certification is preferred. + A minimum of 6 years' experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ICSRs.… more
- BeiGene (San Mateo, CA)
- General Description: _The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... integrated Benefit/Risk assessments. + Promote and Advance the Field of Pharmacovigilance . + Responsible for effective execution, communication and influence with… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid Tumor) to be located in the US (Titusville, NJ; Raritan, NJ; or Horsham, ... Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59023 ... difference, and new people to make a difference with. **The opportunity** Director , Clinical Development is responsible for the development, execution and management… more
- Bristol Myers Squibb (Princeton, NJ)
- …for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety ... least 3 years were dedicated to medical evaluation and operational pharmacovigilance . + Management experience strongly preferred. **Key Competency Requirements** +… more
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