- Gilead Sciences, Inc. (Foster City, CA)
- A leading biopharmaceutical company is seeking an Associate Director for Good Pharmacovigilance Practice Audits in California. This position involves overseeing ... GVP audits, supporting regulatory inspections, and enhancing quality processes. The ideal candidate will have significant experience in quality compliance within the biopharma sector, alongside strong leadership and strategic thinking skills. This role is… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …workplace for employees to grow and develop their skills. Overview The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management ... are met. Additional activities Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF). Represent PV during regulatory inspections or… more
- Ascendis Pharma A/S (Palo Alto, CA)
- A global biopharmaceutical company is seeking an Associate Director for ICSR Management to oversee safety report processes, ensure compliance with regulations, and ... expert. The ideal candidate will have at least 8 years of experience in pharmacovigilance and a relevant degree. This role offers a salary range of $180-195k and… more
- Syneos Health, Inc. (Hartford, CT)
- …at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): ... liaison with study site personnel, or in collaboration with Central Monitoring Associate . Ensures all assigned sites and project‑specific site team members are… more
- Syneos Health, Inc. (Trenton, NJ)
- …at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Assesses site processes. Conducts Source Document Review of ... liaison with study site personnel, or in collaboration with Central Monitoring Associate . Ensures all assigned sites and project-specific site team members are… more
- Syneos Health, Inc. (New York, NY)
- …at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): ... liaison with study site personnel, or in collaboration with Central Monitoring Associate . Ensures all assigned sites and project-specific site team members are… more
- Syneos Health, Inc. (VT)
- …at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): ... liaison with study site personnel, or in collaboration with Central Monitoring Associate . Ensures all assigned sites and project-specific site team members are… more
- Syneos Health, Inc. (Buffalo, NY)
- …safety and data integrity at investigator sites (eg, protocol deviations, pharmacovigilance issues). Per CMP/SMP: assesses site processes, conducts Source Document ... the CRA II may use the business card title of Site Management Associate II. Additional responsibilities include: site support throughout the study lifecycle, chart… more
- AssistRx (Orlando, FL)
- …Leadership in order to effectively maintain program operations and goals. + Monitoring associate calls and providing feedback to program managers on associate ... strengths/coaching opportunities + Reviewing associate case records to ensure program metrics are met + Preparing call center reports and tracking service trends + Participating in the creation and maintenance of program SOP's + Assisting with user… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
