- Regeneron Pharmaceuticals (Warren, NJ)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + ... Ability to work with a safety system database for purposes of medical case review and simple queries + Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize + Ability to effectively communicate… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …/ combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities. + Thorough understanding and application ... of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these… more
- Parexel (Trenton, NJ)
- …of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support * Provide medical input into PV workflows and projects and ... participate in safety processing for studies including medical review of serious adverse events. * Support regulatory safety reporting activities * Ensure client needs and concerns are addressed to ensure customer satisfaction * Actively listen to, solicit and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Clinical Scientist. and other functional areas such as GCO, biostats, regulatory, pharmacovigilance . The Director will be a key contributor to INDs, NDAs, BLAs, ... and other global regulatory filings and publications. The Director will foster relationships with opinion leaders in assigned therapeutic area. The CTP is a member of the study team and CDT. The CTP is expected to advance scientific and clinical knowledge,… more
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