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GPV Case Management Product Specialist
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- Support case processing as a SME for MedDRA coding
- Coordinate internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues
- Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations
- Tasks may include: review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality and listedness assessments, case corrections, and listing reviews
- Perform assigned activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements
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