Pharmacovigilance Report Writer

Job Summary

To support the Benefit Risk group, the full-time office-based Pharmacovigilance Report Writer will author aggregate reports, risk management plans, and signal management reports while ensuring compliance with regulatory standards in Hyderabad.

Key responsibilities

• Author aggregate reports (PSURs/PBRERs, PADERs, Annual Reports) for submission to health authorities
• Conduct literature searches and validate data for aggregate reports
• Provide support for high-priority ad-hoc activities and ensure quality standards are met

Required qualifications

• Bachelor's or master's degree in pharmacy, nursing, life sciences, or a related field
• 6+ years of experience in pharmacovigilance with a focus on medical writing or signal detection
• Experience in authoring and reviewing aggregate reports
• Understanding of ICH-GCP, FDA, and EMA regulations related to pharmacovigilance
• Proficiency in IT and familiarity with MS Office applications