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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