- Genmab (Plainsboro, NJ)
- …internal and external stakeholders; (d) drug safety and/or pharmacovigilance experience; (e) performing ongoing surveillance (including signal detection/evaluation) ... of safety data; and (f) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. All experience may be gained concurrently.#LI-DNIAbout YouYou are passionate about our purpose and… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Global Pharmacovigilance (PV) Senior Scientist , Obesity - US Remote** **Live** **What you will ... world. In this vital role the Global PV Senior Scientist will work within the Therapeutic Safety Teams and...**Basic Qualifications:** Doctorate degree and 2 years of safety/ pharmacovigilance experience OR Master's degree and 4 years of… more
- BeiGene (San Mateo, CA)
- …or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist . OR MD (or internationally recognized equivalent) plus accredited ... **General Description:** _The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Clinical Scientist **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug ... accelerate progress. Join our Immunology and Inflammation Team as Senior Clinical scientist and you'll contribute to bring innovative drugs to patients and make… more
- ThermoFisher Scientific (Waltham, MA)
- …Responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks which are low to medium in ... Essential Functions Serves as a creator/contributor for signal detection and product safety scientist tasks which are low to medium in complexity or which concern… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …practices within Clinical Development. Reports to Manager, Clinical Development Scientist . **Primary Responsibilities:** + Participates in the construct of study ... Generation group such as with Biometry, Clinical Operations, Pharmacology, Pharmacovigilance , and HEOR. + Synthesizes literature and competitive information for… more
- Lilly (Indianapolis, IN)
- …through the practice of pharmacoepidemiology?** We are seeking an ambitious post-doctoral scientist with strong research and communication skills to contribute to a ... used at Lilly. In addition to work associated with TTe, the Post-Doctoral Scientist will have the opportunity to gain first-hand experience with the following: +… more
- Merck (Kenilworth, NJ)
- …NJ will be communicated at a future date. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. ... Cell Sciences (PCS) is seeking a highly motivated and experienced Principal Scientist to help develop and characterize early and late stage mammalian commercial… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + ... Ability to work with a safety system database for purposes of medical case review and simple queries + Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize + Ability to effectively communicate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + You ... demonstrated the ability to contribute positively to a healthy, diverse and inclusive team environment. + Excellent organizational and relationship leadership skills + Strong technical and problem-solving skills/experience. + Ability to build and strengthen… more
- AbbVie (South San Francisco, CA)
- …or related programs. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards ... in conducting research. Contributes to authorship of regulatory responses and actively participates in meetings. + Oversees project-related education of investigators, study site personnel, CRO partners and AbbVie study staff. + Has responsibility for review,… more
- Sanofi Group (Cambridge, MA)
- …review and interpretation, in manuscripts and abstracts preparation + Knowledge of Pharmacovigilance and CMC landscape, of project planning tools + Understanding of ... clinical research process from program planning to regulatory submission **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all Gilead investigational and marketed products. The GHPS ... area trends and their relevance to the Gilead portfolio; Provides pharmacovigilance leadership, oversight, strategic and technical guidance in discussions with teams… more
- Bayer (Boston, MA)
- …of Bayer pharma products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective ... PV Strategy activities throughout product/s lifecycle. This is a senior clinical scientist with deep expertise in clinical medicine, various topics in clinical … more
- Sanofi Group (Bridgewater, NJ)
- …skills could be critical in helping our teams accelerate progress. The clinical scientist is a responsible member of the clinical team dedicated to the development ... of a complex compound program. The primary purpose of the Clinical Scientist 's position is to support the Clinical Research Director (CRD) and/or clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …: You will learn about core Patient Safety Oncology pharmacovigilance activities, including signal detection, benefit-risk evaluation, risk management plans ... under the close supervision of an experienced Global Therapeutic Area (TA) Safety Scientist or Physician. **Key Responsibilities will include, but are not limited to… more
- Kedrion Biopharma (Atlanta, GA)
- **Position Overview** The Associate Scientific Director, Clinical Development, serves as a Clinical Scientist and may act as a delegate of the Therapeutic Area Lead ... data. + Partner with departments such as Regulatory Affairs, Medical Affairs, Pharmacovigilance , and Legal to support clinical trial execution. + Participate in… more
- BeiGene (San Mateo, CA)
- …development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... at least one study through from start to finish in a clinical scientist role + Clinical oncology experience: candidates with exceptional experience in other… more
- Sanofi Group (Cambridge, MA)
- …Clinical Research Directors, Clinical Scientists, Medical review team and Coding + Pharmacovigilance (GSO, CME) as regard to safety management and case processing + ... CTOMs, Biostatisticians + CSU medical advisors for the best knowledge of the study, compound, protocol + TA Experts, GPHs and medical affairs + CROs + Regulatory affairs + Provide input to the study extended synopsis and protocol based on feasibility… more
- BeiGene (Emeryville, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... at least one study through from start to finish in a clinical scientist role. + Clinical oncology experience; candidates with exceptional experience in other… more
