Aggregate Medical Writer - Global Vigilance

About the Role

Fresenius Kabi is expanding its Global Vigilance Medical Writing team and is hiring experienced Aggregate Medical Writers to support global safety surveillance, signal management, and regulatory compliance activities across multiple international markets.

This is a high-impact pharmacovigilance medical writing position for professionals who specialize in aggregate safety report authoring and signal documentation and are seeking global exposure with a structured long-term growth pathway.

Key Responsibilities

Author and review aggregate safety reports including PSURs, PBRERs, RMPs, ACOs, and PADERs
Develop signal evaluation narratives and safety strategy documentation
Conduct systematic literature reviews to identify safety signals and emerging risks
Ensure compliance with global pharmacovigilance regulations and internal SOPs
Collaborate with safety physicians, PV operations teams, and regulatory stakeholders
Support benefit-risk evaluations and regulatory submissions
Maintain inspection-ready documentation and reporting standards

Eligibility Criteria

Education (Mandatory): PhD / PharmD / M.Pharm / BDS
Experience: 4–9 years in pharmacovigilance medical writing
Core Expertise:
PSUR / PBRER / RMP / ACO / PADER authoring
Signal evaluation & narrative writing
Regulatory compliance & literature review
Work Mode: On-site – Gurgaon (1-day flexi WFH)

Why Fresenius Kabi?

Global exposure to high-impact pharmacovigilance programs
Career progression in one of the world’s most respected healthcare organizations
Structured learning and professional development programs
Collaborative global PV culture with inspection-ready processes
Highly competitive compensation