Job Title: Senior Safety Writer
Job Location: Mumbai, Maharashtra, India
Job Location Type: On-site
Job Contract Type: Full time
Job Seniority Level: Mid-Senior level

Job Overview

Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Be responsible for end-to-end report management, including planning, authoring, and managing review, approval, and submission steps, per project scope and requirements. Apply safety domain knowledge and process expertise to manage deliverables of medium to high complexity. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Coach, mentor, and provide shadowing opportunities and hands-on experience for the training and development of medical writers and junior associates. Support project management activities. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary Of Responsibilities




- Write and review various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Report, ACOs, Addendum reports, as assigned.
- Author and review RMPs, adhoc reports, Benefit-Risk Evaluation reports, medical device reports.
- Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
- Conduct training for peers and junior team members, provide shadowing opportunities and hands-on experience.
- Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback.
- Author/review manuscripts, abstracts, poster

📌 Senior Safety Writer (Mumbai)
🏢 Lifelancer
📍 Mumbai