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GPV Case Management Product Specialist

4 months ago

Trenton, United States GForce Life Sciences Full time

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a GPV Submission Specialist responsible for managing daily operational activities of the Global Submissions Team within Case processing.

Description

  • 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 listed 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, other guidance/training documents
  • Lead and provide safety operations support on assigned studies
  • Support PV Inspection/Audit activities or Health Authority requests


Qualifications/Experience

  • Degree preferred to be in Bachelor of Science or related healthcare degree
  • 7-10 years of pharmacovigilance progressive experience required


Required Skills Include:

  • 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
  • Knowledge and experience with working on expedited ICSR submissions to Health Authorities
  • Knowledge of Medical device submissions
  • Knowledge of expedited ICSR submissions to Ethics Committees and Investigators
  • Product configuration management experience
  • Signal detection management experience


Term & Start

  • 12-month contract, open to 12+ month extension
  • 2 Video Interviews - Start 2-3 weeks from an offer
  • Full-time, 40 hours/week
  • Hybrid – Onsite 2 days a week onsite
  • Benefits available (Medical, Dental, Vision, 401k)