GPV Specialist

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)