- Takeda Pharmaceuticals (Boston, MA)
- …implementation and management of effective structure, procedures, and tools to ensure aggregate report and other functional deliverables are completed with high ... the Patient Safety & Pharmacovigilance (PSPV) team, you will report to the Director and Head, PV...+ Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports . + Establishes and chairs document… more
- Bristol Myers Squibb (Princeton, NJ)
- …and submissions. . Provide medical safety, benefit-risk input for safety aggregate reports , product renewal submissions, postmarketing study documents and ... work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area… more
- Taiho Oncology (Princeton, NJ)
- … opinion. Drafts the appropriate safety sections as well as Risk/benefit sections for aggregate safety reports . + Provides medical opinion and safety input ... Sr. Director , PV Medical Surveillance Princeton, NJ,...of benefit-risk profile for assigned products and review of aggregate reports . Responsible for keeping upper management… more
- BeiGene (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... report for inclusion into clinical, filing, and post-market reports + Accountable for daily, weekly, and monthly review...on the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US - Remote Opportunity Requisition ID: 5424 Location: Deerfield, IL, US Do you want to join a team where the ... post marketing and clinical trial ICSRs, and instructs staff for appropriate follow-up ** Aggregate Reports (eg PSUR/PBRER, DSUR, PADER)** + Responsible for the… more
- Quinnipiac University (Hamden, CT)
- Overview: Quinnipiac University's School of Medicine is seeking an Assistant Clerkship Director in Obstetrics and Gynecology. The Assistant Clerkship Director is ... responsible for collaborating with the Obstetrics & Gynecology Clerkship Director to oversee the educational experiences within the Obstetrics & Gynecology clerkship… more
- University of Michigan (Ann Arbor, MI)
- …to the Department Chair Direct Reports : All faculty in the center report directly to the Director . The Center Administrator and specific administrative staff ... of the University. + Promote a collaborative, collegial culture throughout the Center. **Reporting Relationships** Reports to: The Director reports directly… more
- Western Washington University (Bellingham, WA)
- …Director of Clinical Operations Apply now ... Bellingham, WA Categories: Enrollment & Student Services Position TitleAssistant Director of Clinical Operations About the University Western Washington University,… more
- ThermoFisher Scientific (Wilmington, NC)
- …**Marketed Products Support:** Manages signal detection activities, scientifically reviews aggregate reports , contributes to label updates, supports dossier ... safety and efficacy data) and/or review of CSR, IND/NDA report , ICSR, signal detection reports , periodic ...+ Direct experience in safety/Pharmacovigilance (comparable to 2 years) Medical Director level requires: + Clinical experience… more
- Adecco US, Inc. (Alachua, FL)
- Adecco Healthcare & Life Sciences is hiring a remote contract Senior Medical Director - Nephrology for our Pharmaceutical partner based out of Alachua, FL. The ... **Marketed Products Support:** . Manages signal detection activities, scientifically reviews aggregate reports , contributes to label updates, supports dossier… more
- ThermoFisher Scientific (Juneau, AK)
- …concerns. Marketed Products Support: + Manages signal detection activities, generates aggregate reports , contributes to label updates, supports dossier ... in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report , ICSR, signal detection reports , periodic reports , RMP, REMS,… more
- Pfizer (Pearl River, NY)
- …+ Monitor study safety issues and provide input to serious adverse events (SAEs) reports . + Provides appropriate medical context in terms of risk factors, ... report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall… more
- J&J Family of Companies (Cincinnati, OH)
- Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Biosurgery and Endomechanical to be located in Cincinnati, OH or Raritan, NJ. At Johnson ... to the following: + Assess product risk-benefit and provide medical input/review to: + Risk Management Reports ...+ Clinical interpretation of: + Post-marketing safety data + Aggregate complaint data + Individual case safety reports… more
- AbbVie (North Chicago, IL)
- …but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports . + Apply current regulatory guidance as appropriate for safety ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...authorship of safety documents + Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation… more
- AbbVie (North Chicago, IL)
- …for an asset or group of assets, the AMD will collaborate with the Group Medical Director to develop of best practices in patient safety across innovative ... guidelines. + Support the combination safety management strategy (SOPs, aggregate reports , SSL, etc.) and liaises with...programs + May serve as delegate for the Group Medical Director on the Platform Assimilation and… more
- BeiGene (San Mateo, CA)
- …regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic ... **General Description:** _The Director , Safety Scientist supports assigned compounds in conjunction...Experience Report (PAER), Periodic Safety + Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs),… more
- Amgen (Washington, DC)
- …for a career you can be proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US - Remote** **Live** **What you will do** ... risk minimization measures + Prepare/review safety sections of periodic aggregate reports + Provide safety input to...**Basic Qualifications:** MD or DO degree from an accredited medical school AND Completion of an accredited medical… more
- Boston College (Chestnut Hill, MA)
- …**Position Summary** The ILHPR seeks an ambitious, entrepreneurial, and thoughtful Research Director to help build up the Initiativea€ (TM) s research program so ... and doctrinal, a research method many legal academic researchers use. The Research Director will manage and support members of the research team, including the… more
- CAMBA (Brooklyn, NY)
- …care management agency, providing clients with personal care coordinators. Position: Compliance Director Reports Chief Legal Officer Location: 2244 Church Avenue ... not limited to the lead Health Homes, Medicaid, DOHMH and DOH. + Record, aggregate , analyze and report results of HealthLink program activity audits, identifying… more
- Disney Entertainment (New York, NY)
- Disney's Addressable Ad Operations team is seeking a Director , Ad Operations who will be responsible for setting the strategy, direction and management of the ... account management team. The Director , Ad Operations will directly manage Sr. Managers who...the business. **Job Summary:** In this role you will report into the VP of Ad Operations and will… more