GPV Case Management Product Specialist
3 weeks ago
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)
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GPV Case Management Product Specialist
3 weeks ago
Trenton, United States GForce Life Sciences Full timeSummaryOur 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. DescriptionMonitor and manage the ICSR workflow for assigned projects and products to ensure all deadlines are met and...
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