Pharmacovigilance Risk Management Specialist

Job Summary

Leading the development and maintenance of Pharmacovigilance Risk Management Plans (PV-RMPs), the full-time Pharmacovigilance Risk Management Specialist will ensure compliance with regulatory requirements while collaborating with cross-functional teams to support patient safety initiatives in a remote work environment.

Key responsibilities

• Serve as the primary author of PV-RMPs, ensuring adherence to global regulatory standards
• Coordinate cross-functional review and approval processes for PV-RMPs and respond to regulatory authority inquiries
• Manage project timelines and deliverables related to risk management plans independently

Required qualifications

• Bachelor's degree in Nursing, Biological Sciences, Medical, Clinical, or a related field
• Minimum two years of pharmaceutical industry experience in Pharmacovigilance or related functions
• Two to three years of experience authoring Pharmacovigilance Risk Management Plans (PV-RMPs)
• Knowledge of global PV-RMP regulations and regulatory submission requirements
• Experience interacting with regulatory authorities and addressing health authority inquiries