- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- US Tech Solutions (Plainsboro, NJ)
- …PV case handling from case intake to submission of Individual Case Safety Reports (ICSRs) 3. Management experience **Job Requirements:** * In-depth ... pharmacovigilance case handling from case intake to submission of Individual Case Safety Reports (ICSRs) * Extensive quality control of ICSRs to ensure compliance… more
- United Therapeutics (Annapolis, MD)
- …and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety ... ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting… more
- BeOne Medicines (Boston, MA)
- …leadership, clinical operations, legal, compliance, new product planning, safety / pharmacovigilance , molecular diagnostics, marketing, sales and translational ... research. The incumbent will play a key role in the establishment of BeOne as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** Vermont, New Hampshire, Maine, Massachusetts, Connecticut, Rhode Island Essential… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …alignment amongst relevant functional groups + Review of report from Drug Safety / Pharmacovigilance , as needed + Preparing for and participating in product ... Scientific Advisory Boards for products both marketed and in development + Complete all company and job-related training as assigned within the required timelines. **Job Requirements:** + Relevant science degree (ie, PhD, PharmD, MD; Master's degree considered… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- BeOne Medicines (San Mateo, CA)
- …leadership, clinical operations, legal, compliance, new product planning, safety / pharmacovigilance , molecular diagnostics, marketing, sales, and translational ... research. The incumbent will play a key role in establishing BeOne Medicines as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** (SC, GA, FL, AL, MS) **Essential Functions of the job:** + Work with Cross-functional… more
- BeOne Medicines (San Mateo, CA)
- …leadership, clinical operations, legal, compliance, new product planning, safety / pharmacovigilance , molecular diagnostics, marketing, sales, and translational ... research. The incumbent will play a key role in the establishment of BeOne Medicines USA, Inc. as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** OH, IN, KY, WV, VA, TN, MD, DE **,** **Essential Functions of the… more
- Nestle (Bridgewater, NJ)
- …of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering automation, regulatory ... compliance, quality management and compliance, medical information, or clinical trials applications. + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations. +… more