- Sanofi Group (Cambridge, MA)
- …safety input into development plans + Support due diligence activities and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the ... is preferred + Minimum 3 years' total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development) with… more
- Astellas Pharma (Northbrook, IL)
- …Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV). + Demonstrated success working with key external ... including presenting/responding to health authorities. + Knowledge of global pharmacovigilance standards and guidance documents. Comfortable working in a flexible,… more
- Astellas Pharma (Northbrook, IL)
- …and partner closely with Development, Medical Affairs, and Pharmacovigilance /Pharmacoepidemiology colleagues in their research. Additionally, you will collaborate ... and Biostatistics colleagues and cross-functional teams in Development, Medical Affairs and Pharmacovigilance + Mentor and guide junior members of the RWD Analytics… more
- Sanofi Group (Morristown, NJ)
- …Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (eg planning and review of narratives) ... safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance . **About You** **Knowledge And Skills Required** : + Ophthalmology/retina clinical… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …to support pipeline planning as well as US safety and pharmacovigilance activities, (3) development of strategically aligned scientific publications using real-world ... of IND submissions, clinical trial applications, filing procedures, or pharmacovigilance /safety inquiries. + Develop, execute and deploy integrated evidence… more
- Deloitte (Morristown, NJ)
- …include: + Project Leadership: Lead the delivery of and pharmacovigilance projects, including business process transformation, technology enablement, and regulatory ... Engineering, or related field + 4+ years of experience in life sciences, pharmacovigilance , or consulting + 4+ years of experience implementing and working with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ MD or equivalent with 4+ years of experience in drug safety/ pharmacovigilance , with a focus on clinical trials and cross-functional collaboration **Preferred ... Qualifications:** + 5+ years of experience in drug safety/ pharmacovigilance , with a focus on clinical trials and cross-functional collaboration. + Completion of… more
- Ascendis Pharma (Palo Alto, CA)
- …+ Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / ... experience is highly desired. + Minimum of 4 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus preferred) +… more
- Sanofi Group (Cambridge, MA)
- …with Scientific Communication team, other internal stakeholders such as R&D, Pharmacovigilance , contributors, and vendors/agencies. + Contribute to the annual and ... AdBoards, and innovative projects. + Ensure medical support to R&D, Pharmacovigilance and Regulatory activities including risk management and health authority… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices + Ability to apply and provide critical analysis of relevant ... FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. +… more