Safety Medical Writer

Why This Role Matters

Safety Medical Writers play a crucial role in evaluating and communicating the benefit–risk profile of medicinal products through structured regulatory documents. Aggregate reports such as PSUR, PBRER, PADER, and RMP are essential for maintaining product approvals and ensuring ongoing patient safety in global markets.
At Fidelity Health Services, the Safety Medical Writer contributes to high-quality aggregate report preparation, regulatory compliance, and client-focused pharmacovigilance operations.

Job Description

Fidelity Health Services is hiring a Safety Medical Writer for its Mumbai location. The role focuses on drafting, reviewing, and managing Aggregate Reports (ARs) including PSUR, PBRER, PADER, RMP, and Annual Safety Reports.
The selected candidate will collaborate with ICSR teams, regulatory stakeholders, and global clients to ensure accurate data compilation, medical evaluation, and timely regulatory submissions.

Key Features of the Role

• Hands-on experience in aggregate safety report writing
• Exposure to global regulatory reporting requirements
• Direct coordination with clients and cross-functional PV teams
• Involvement in submission planning and strategy
• Growth opportunity in medical writing and risk management

Responsibilities

• Draft and quality review PSUR, PBRER, PADER, RMP, and Annual Safety Reports
• Develop submission strategies and ensure adherence to timelines
• Conduct kick-off meetings with clients and internal stakeholders
• Generate line listings and summary tabulations from processed ICSRs
• Review XML data extracted from global safety databases
• Identify safety signals and data inconsistencies
• Ensure compliance with global regulatory guidelines
• Maintain documentation for audit readiness
• Resolve issues related to aggregate report preparation
• Support additional pharmacovigilance and medical writing activities

Required Qualifications

• 2–3 years of experience in aggregate safety report drafting and review
• Strong knowledge of global PV regulatory frameworks
• Experience handling PADER, PSUR, PBRER, and RMP documentation

Educational Requirements

• M.Pharm
• B.Pharm
• BAMS
• BHMS
• BDS

Experience and Skills

• Strong medical writing and analytical skills
• Knowledge of ICSR processing and safety databases
• Experience in line listing and tabulation generation
• Familiarity with XML data extraction
• Good understanding of benefit-risk evaluation concepts
• Strong communication and stakeholder coordination skills
• Detail-oriented with strong compliance focus

Salary Insights

• Competitive compensation based on experience and expertise
• Exposure to global regulatory markets
• Career progression in medical writing and risk management

Company Overview

Fidelity Health Services is a pharmacovigilance and regulatory services organization offering comprehensive drug safety solutions to global pharmaceutical clients. The company specializes in aggregate reporting, reconciliation management, compliance monitoring, and regulatory documentation.

FAQs

Q: Is aggregate reporting experience mandatory?
Yes, hands-on experience in drafting PSUR/PBRER/PADER/RMP is required.

Q: Does the role involve client interaction?
Yes, coordination with clients and internal stakeholders is part of the role.

Q: Is healthcare professional qualification acceptable?
Yes, candidates with BAMS, BHMS, BDS, B.Pharm, or M.Pharm qualifications are eligible.

Application Tips

• Highlight number and type of aggregate reports handled
• Mention global markets supported (US, EU, ROW)
• Include safety database experience
• Showcase medical writing and regulatory compliance expertise