- 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 (NJ)
- …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
- 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... (FDA, Health Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements. + Maintains thorough… more
- Sanofi Group (Morristown, NJ)
- …(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, safety surveillance) + ... May represents Sanofi Vaccines BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees + May act as the lead statistician at clinical trial level and provides… more
- Sumitomo Pharma (Trenton, NJ)
- …and effectiveness checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department activities as ... (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will...Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team… 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