- ThermoFisher Scientific (Wilmington, NC)
- …to present services to sponsors and prepare effective proposals for Pharmacovigilance and Regulatory Affairs activities which include the specific value proposition ... instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees Thermo Fisher Scientific… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety & Pharmacovigilance (PSPV) team you will report to the Executive Director , PV Operations Oversight, and be responsible for ensuring operational ... to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Pharmacovigilance (PV) Operations in Cambridge, MA, where you will… more
- BeiGene (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs ... pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and.../ portfolio being led. The Executive Medical Director serves as Product Safety Physician Lead… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Director has responsibility for pharmacovigilance risk management activities of marketed and/or investigational compounds on global level. ... updates or coach direct reports to provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Executive Medical Director is responsible for the safety strategy for Hematology late-stage ... in the Oncology TA. The Executive Medical Director will be the oncology safety team...Clinical Development + Direct Experience in NDA submissions from pharmacovigilance /Clinical development side is required. + At least 3… more
- BeiGene (San Mateo, CA)
- The Executive Medical Director will support BeiGene Clinical and Medical assets within the Hematology franchise by successful development of early and late phase ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational research.… more
- Lilly (IN)
- …trials, the reporting of adverse events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination ... trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management). **Additional Skills/Preferences** + Pharmaceutical company… more
- AbbVie (Jersey City, NJ)
- …trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - … more
- AbbVie (Jersey City, NJ)
- …with preclinical, clinical pharmacy, clinical development, and discovery + Works closely with Executive Medical Director to establish safety strategy for ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on… more
- Amgen (Washington, DC)
- …(SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the ... proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US...and related conditions experience. + 2 years of industry pharmacovigilance (PV) experience + Product safety in… more
- AbbVie (North Chicago, IL)
- …the direction of the Immunology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for one or more assets ... and regulations impacting the functions of regulatory science and pharmacovigilance , as applicable to RWD/RWE. Responsibilities: + Represent Global Epidemiology… more
- Takeda Pharmaceuticals (Lexington, MA)
- …knowledge. **Job Description** **About the role:** Join Takeda as an Associate Director , Market Research and Competitive Intelligence, where you will be responsible ... recommendations and market intelligence insights to commercial brand, medical, forecasting, and executive teams to inform decision making. + Owns and executes CI… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... suffering from immunological diseases. Position Summary: We seek an Associate Director , Quality Assurance to join an experienced, fast-paced and collaborative team.… more
- BeiGene (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... **General Description:** The Associate Director - Clinical Science will support BeiGene Clinical and Medical assets by successful execution of clinical development… more
- BeiGene (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... **General Description:** The Director , Clinical Science will support BeiGene Clinical and...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports. + Clinical sections of Health Authority… more
- CSL Behring (King Of Prussia, PA)
- …this role from others (2 - 3 sentences). The purpose of the position of Executive Director R&D Quality is to lead a dedicated team responsible for quality ... execution of the QMS specifically for Clinical and Combination Products/Medical Devices, Pharmacovigilance and Safety . Responsible for the execution of the… more