- BeOne Medicines (Emeryville, CA)
- General Description: _The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and… more
- Astellas Pharma (Northbrook, IL)
- …packages. The VP will partner with key stakeholders in development, pharmacovigilance , clinical operations, medical affairs, and commercial strategy to drive an ... approaches in portfolio decisions. + Support clinical development, regulatory, pharmacovigilance , and medical affairs by integrating RWE into clinical plans,… more
- J&J Family of Companies (Raritan, NJ)
- …the field and cementing role as KOL in the field. + Safeguard patient safety . Support Sr. Medical Director in Pharmacovigilance activities, reviewing periodic ... pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and product launch and training for key products… more
- BeOne Medicines (San Mateo, CA)
- **_General Description:_** The Senior Manager, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) to conduct signal ... detection, evaluation of safety data, assessment of safety risks, responses...integrated Benefit/Risk assessments Promote and Advance the Field of Pharmacovigilance . Any other tasks assigned by manager to… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US Requisition ID: 5424 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... growth! **SUMMARY:** This position is responsible for strategically managing the safety surveillance and risk minimization activities for assigned Lundbeck products… more
- AbbVie (North Chicago, IL)
- … pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory ... pipeline and considered for future opportunities. Medical Directors within the Patient Safety , Epidemiology and Quality team are responsible for the following: 1.… more
- Belcan (Mason, OH)
- …archives registration files. Ensures that all the aspects of the product safety are closely monitored and fulfill the pharmacovigilance /regulatory requirements - ... Requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills - Builds knowledge of the organization, processes and customers. If you are interested in this role, please apply via the apply now link provided. Our… more
- United Therapeutics (Phoenix, AZ)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Rhythm Pharmaceuticals (Boston, MA)
- …as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more