GPV Case Management Product Specialist

2 weeks ago

Princeton, United States GForce Life Sciences Full time
Job DescriptionJob DescriptionResponsibilities
  • Monitor and manage the ICSR workflow for assigned projects and products to ensure all deadlines are met and compliant with safety reporting obligations
  • Support PV Management in the oversight of Case Management vendors: triage, troubleshooting problems, escalation as necessary
  • Perform and/or oversee the collecting, documenting, and processing of adverse event (AE) reports from clinical trials and post-marketing sources
  • Supervise follow-up activities with consumers and/or healthcare professionals
  • Support case processing as a SME for MedDRA coding
  • Support management as SME for ICSR handling during PV-related regulatory inspections or internal quality assurance/corporate compliance audits
  • Management and oversight of PV vendor(s)
  • Support PV management in the oversight of vendor-supported ICSR processing
  • Coordinate internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues
  • Support PV management in investigation, root cause, corrective and preventive actions related to internal and external PV-associated CAPA findings
  • Participate in training activities related to Case Management
  • Support PV Management with various functional areas supporting ICSR handling (i.e. intake, literature handling, follow-up, alliance management)
  • Support the Clinical Research Department as an SME for case processing
  • Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations
  • Serve as PV SME for associated projects/product-related meetings/committees
  • Assist in the generation of database queries for AE listings
  • May include the need for end-to-end case processing including but not limited to: Triage, Data Entry, Assessment, Quality Review, query generation, manufacturer notifications, and coding. Tasks may include: review of source information, MedDRA coding, narrative preparation, preliminary seriousness, causality and listedness assessments, case corrections, and listing reviews
  • Participate in User Acceptance Testing activities for Case Management Initiatives
  • Perform assigned activities in accordance with Otsuka Standard Operating Procedures, and regulatory requirements
  • Support guidance document development and updates including but not limited to PVAs, SMPs, SOPs, and other guidance/training documents
  • Lead and provide safety operations support on assigned studies
  • Support PV Inspection/Audit activities or Health Authority requests

Required Experience
  • Bachelor's degree in a scientific field, preferably in the health sciences area (e.g., Nursing, Pharmacy)
  • 8-10 years of pharmacovigilance progressive experience required
  • Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
  • Knowledge of the ARGUS Safety Database
  • Knowledge and prior experience in case processing
  • Signal detection management experience
  • Product configuration management experience
  • Knowledge of the interworking of Global Pharmacovigilance organization is desired
  • Experience with managing vendors, partners, and/or CRO's preferred
  • Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources
Term & Start
  • 12+ month contract (opportunity to extend)
  • Start ASAP
  • Hybrid 2x/week in Princeton, NJ
  • Benefits available (Medical, Dental, Vision, 401k)
  • $50-55

 

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