- Support the oversight and management of the case processing activities outsourced to PV Vendor
- Manage the study or product configuration request process for the global safety database
- Work with Clinical Study and Medical Safety Teams to support assigned products in case processing-related activities
- Assist with Individual Case Safety Report improvement efforts and compliance activities.
- Responsible for maintenance of the safety database to ensure compliance in ICSR quality and regulatory reporting
- Assist with generating AE listings from safety database
- Responsible for Pharmacovigilance Agreements (PVAs) and Safety Management Plans (SMPs) case management review
- Support PV Inspection/Audit activities or Health Authority requests as required
- Bachelor degree in a scientific field, preferably in health sciences area (e.g., Nursing, Pharmacy)
- 5+ years of pharmacovigilance progressive experience required with minimum 2+ years of ICSR case processing experience
- Sufficient experience and demonstrated knowledge understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
- ARGUS Safety Database knowledge
- MS Office proficiency
- Knowledge and prior case management experience in case processing
- Experience with oversight of vendors and CRO partners
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
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Global PV Case Management Specialist - Princeton, United States - Solomon Page
Description
Our client, a leading pharmaceutical company, is looking for a Global PV Case Management Specialist in Princeton, NJ. This role is hybrid and will have a 1 year contract duration to start.
Responsibilities:
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .
Opportunity Awaits.
