- Takeda Pharmaceuticals (Cambridge, MA)
- …programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences and data architecture/governance) bring ... their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DSI, the… more
- AbbVie (North Chicago, IL)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications Qualifications + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program… more
- AbbVie (Irvine, CA)
- …for key regulatory discussions. *Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications *Bachelors degree in the sciences; advanced degree (eg, MS, PhD, OD, MD, PharmD) preferred. *At least 8 years of product development experience with 5 years of experience in consumer eye care in the… more
- Arvinas (New Haven, CT)
- …research physician + Partner with Clinical Operations, Translational Medicine, Pharmacovigilance , Data management and other functional team members at assure ... quality and timely study conduct and monitoring + Provide support as needed for clinical and scientific issues that may arise during study execution + Work closely with biostatisticians and programmers to plan analyses of clinical data + Support data summaries… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Quality/Compliance experience. + Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and ... relevant regulations. + Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and… more
- Astellas Pharma (Northbrook, IL)
- …statistics, medical affairs statistics, real-world evidence (RWE), safety/ pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and ... advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key… more
- Ascendis Pharma (Palo Alto, CA)
- …about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to ... role The role of Program Safety Lead is a director level position here at Ascendis and this Lead...a pivotal role as the Program Safety Lead and pharmacovigilance expert for the Ascendis' endocrinology pipeline. As a… more
- Merck (Rahway, NJ)
- …our company and will be a key growth driver for our company. The Director , Global IBD Patient Strategy is responsible for shaping the global strategy and framework ... patient access and are competitive with existing market offerings. The Director will partner cross-functionally with global and ex-U.S. commercial, medical, access,… 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
- Merck (Rahway, NJ)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... technology and applying rigorous scientific and ethical standards. The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and… more