- Sanofi Group (Cambridge, MA)
- …Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. ... needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities… more
- Bristol Myers Squibb (Phoenix, AZ)
- …Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing ... external communication when significant safety issues arise, with the well-being of patients being the goal + Understands and adheres to the BMS Standards of… more
- Merck (Lower Gwynedd, PA)
- …Standard Operating Procedures to ensure compliance with GxP Practice and corporate safety requirements. + Enhance the existing LAMP infrastructure to track equipment ... (ICT), Maintenance Management, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance , Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications,… more
- ThermoFisher Scientific (Carlsbad, CA)
- …effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best ... Deep knowledge of clinical program and study design, relevant endpoints, safety considerations and current regulatory and commercial landscapes. + Commercial acumen… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance , market access and commercial perspective as well as engage ... meetings including briefing documentation. + Provide global regulatory input to critical safety or quality communications. + Maintain global oversight of local RA… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …related to protocol conduct and data quality and integrity. + Assesses overall safety information for studies and compound in conjunction with the study medical ... director and Pharmacovigilance . + May oversee other clinical scientists with respect to assessment of these issues. + Informs final decisions regarding study conduct… more
- Boehringer Ingelheim (Ridgefield, CT)
- …area from the regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance , market access and commercial perspective. This role provides ... within strategic priorities. + Lead the preparation and distribution of critical safety or quality communications in the US, with guidance from management and… more
- AbbVie (South San Francisco, CA)
- …interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews literature to ... for late-stage assets. * Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards… more
- AbbVie (Irvine, CA)
- …interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in aesthetic indications. Along with Clinical Operations, ... health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- Sanofi Group (Morristown, NJ)
- …development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver ... benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify,… more