Patient Safety Specialist
virtual vocationsNew York, NY
Patient Safety Specialist
General Medical and Surgical HospitalsPharmaceutical Preparation ManufacturingAll Other Miscellaneous Ambulatory Health Care Services
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
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Level
Senior L5
Location
New York, NY
Occupation
Regulatory Affairs Specialists
Industry
General Medical and Surgical Hospitals
Posted
3 days ago