Patient Safety Specialist

Job Summary

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 communication

Required 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