Job Title: Senior Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 251685
Job Overview:
Lead preparation and review of safety-related regulatory documents, manage full report life cycle (planning, authoring, review, approval, and submission), and ensure timely, high-quality deliverables. Guide and mentor junior team members, support project management, and maintain strong client relationships.
Summary of Responsibilities:
Author and review safety reports: Annual Reports, PSURs, PADERs, PBRERs, DSURs, ACOs, Addendums.
Draft and review RMPs, benefit-risk reports, medical device reports.
Write CTD Summaries (Non-Clinical, Clinical Overviews, Summaries).
Train and mentor junior writers; provide hands-on learning and coaching.
Draft health authority response documents in collaboration with cross-functional teams.
Write scientific publications: manuscripts, abstracts, posters.
Support medical information queries and author responses.
Perform and review signal detection tasks, strategy development, and evaluations.
Author/review ad hoc signal reports and safety issue analyses.
Develop SOPs, WIs, and other process documentation.
Coordinate report writing activities across teams if applicable.
Conduct tracking, quality checks, and training activities.
Assist in RFP responses and resource estimations.
Manage client communications and issue resolution.
Prepare and revise labeling documents (CDS, USPI, SPCs, Med Guides).
Conduct literature reviews for report authoring and surveillance.
Promote quality and compliance across all documentation.
Perform additional tasks as assigned.
Qualifications (Minimum Required):
Bachelor's degree in Life Sciences (or equivalent).
4+ years in the pharmaceutical industry, with at least 3 years in medical writing.
Excellent command of English (written and spoken).
Strong MS Office, communication, and organizational skills.
Familiarity with regulatory requirements, PV practices, and ICH GCP guidelines.
Preferred Qualifications:
Advanced degree (e.g., Master's or PhD).
Scientific or clinical research experience.
Work Environment:
Office or remote setup.
Up to 10% travel, including overnight stays, as per project needs.
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