- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compounds in conjunction with Pharmacovigilance . + **External Interactions** + Directs activities involved in interactions ... with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …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
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Key roles and Responsibilities:** + Key contributor in Clinical development strategy, planning and leading presentations to various internal governance committees + Provides leadership and clinical oversight across all assigned studies and programs (up to 2… more
- Sanofi Group (Cambridge, MA)
- …input into development plans + Support due diligence activities and pharmacovigilance agreements **Signal Detection & Assessment** + Responsible for signal detection ... and analysis + Collaborate with Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group + Identify and implement proactive safety analysis strategies to further define the safety profile + Lead aggregate safety data review… more
- University of Maryland, Baltimore (Baltimore, MD)
- …science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical Research; Pharmacovigilance ; Phase IV Research (eg, Pharmacoepidemiology); and Drug and ... Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory science, which is the first two courses in the MS in Regulatory Science. The student population for the program possess a diverse range of backgrounds including regulatory… more
- Lilly (IN)
- …the therapeutic area. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards ... in conducting research. **Minimum Requirements:** + Expertise in radiopharmaceutical/internal dosimetry using MIRD-based and voxel-based dosimetry software + Demonstrated ability to communicate dosimetry and/or modeling results to a multidisciplinary audience… more
- AbbVie (Mettawa, IL)
- …role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of ... the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and… more
- AbbVie (Mettawa, IL)
- …ethical standards. . Collaborate with Regulatory Affairs, Legal, Compliance, and Pharmacovigilance teams to ensure adherence to internal processes, policies, and ... external regulations. . Participation in design and execution of clinical trial safety, product safety and risk management plans. . May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …& Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance to implement discovery and development toxicology strategies that enable ... the progression of optimized drug candidates. + When appropriate, take lead to develop plan and lead sub-team for investigative studies to support investigations on mechanisms of toxicity. + Serve as NDS Therapeutic Area lead, and/or provide guidance and… more
- Nestle (Bridgewater, NJ)
- …manufacturing systems and processes supporting drug safety, pharmacovigilance , manufacturing, engineering automation, regulatory compliance, quality management ... and compliance, medical information, or clinical trials applications. + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations. + Knowledge of systems software,… more