- Takeda Pharmaceuticals (Cambridge, MA)
- …activities, assessing issues related to protocol conduct and/or individual subject safety . Assesses overall safety information for studies and compound ... in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of these issues. + Makes final decisions regarding study… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + **Audit Management:** Oversee the planning, execution, ... Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data… more
- J&J Family of Companies (Titusville, NJ)
- …partnership: Works with Program owners, HCC, Privacy, Law Department, Finance, Pharmacovigilance , Strategic Insights and Analytics (SIA), Safety Services, CSC, ... Procurement, Brand Teams and vendors to ensure a smooth implementation of channel strategies + Deliver outstanding project management and clear communication between delivery model service providers and internal subject matter experts + Demonstrates… more
- Sanofi Group (Seattle, WA)
- …relevant products in the Vaccine portfolio and pipeline. + Good knowledge of pharmacovigilance and local regulatory process and its impact on the Vaccine portfolio + ... car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and… more
- AbbVie (North Chicago, IL)
- …and the review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical ... key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- Sanofi Group (Miami, FL)
- …Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. ... when needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Maintains awareness of clinical trial… more
- Astellas Pharma (Northbrook, IL)
- …insights into regional and global strategy + Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety ... reports, as applicable + Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee, as applicable + Provide medical expertise related to new product licensing and acquisition opportunities for the US… more
- Sanofi Group (Cambridge, MA)
- …science organization, and various R&D functions such as patient safety /pharmocovigilance, patient focused drug development, portfolio management, global regulatory ... novel project deliverables requiring EGDS expertise, including innovations in pharmacovigilance , portfolio management, patient-centric early development including diversity in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. **Additional Duties & ... with preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with… more
- AbbVie (North Chicago, IL)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more