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Supporting pharmacovigilance operations remotely, the full-time Patient Safety Specialist will manage PV package preparation, perform quality control reviews, and oversee mailbox operations while ensuring compliance with regulatory standards.
Key responsibilities: Manage end-to-end PV package preparation and documentation control Perform quality reviews of safety cases and documentation for accuracy and compliance Oversee PV mailbox operations, including query triage and stakeholder communicationRequired qualifications: Bachelor's/PG degree in Life Sciences, Pharmacy, or relevant fields 3-5 years of experience in Pharmacovigilance Operations Strong understanding of PV processes, adverse event management, and safety documentation Expertise in maintaining inspection-ready documentation and compliance with GVP/GCP requirements Proficiency in safety databases and PV tracking platforms

Also on the board Same function, level within a rung

Level

Senior

Location

New York, NY

Occupation

Regulatory Affairs Specialists

Industry

General Medical and Surgical Hospitals

Posted

2 days ago

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