- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... (SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives,… more
- United Therapeutics (Trenton, NJ)
- …You are passionate about PV and enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and ... safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality , and compliance impacts. This role is critical in ensuring that… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Global Patient Safety Medical Science reports to Head of GPS ... + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Data Management Processes, Training and Inspection Readiness, ... safety and pharmacovigilance , CROs and other vendors to ensure high quality of deliverables to support drug development processes and global submissions. This… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Laboratory Data Management is accountable for the ... safety and pharmacovigilance , CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global… more
- Haleon (Warren, NJ)
- …supplements. In line with a risk-proportionate framework for product vigilance, the ** Associate Director , Consumer Safety Science** is accountable for developing ... + 5 years+ experience in similar role with extensive knowledge in pharmacovigilance . + In-depth knowledge in causality assessment, evaluation of safety signals and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …research through post-marketing + Strong experience in Good Clinical and Good Pharmacovigilance Practices and knowledge of evolving regulations, such as ICH E6 R3 ... Proven experience advising business functions in the biopharma industry on quality and compliance requirements and continuous improvement + Experience working across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices: Reinforces labeling… more