Job Title: Senior Safety Writer
Location: Mumbai, India (Remote)
Job Type: Full-Time
Job ID: 256140
Posted: 3 Days Ago
Application Deadline: February 13, 2026
Job Category: Pharmacovigilance / Medical Writing / Drug Safety / Regulatory Writing
Job Overview
We are seeking an experienced Senior Safety Writer to lead the preparation and review of aggregate safety reports, risk management documentation, signal detection analyses, and benefit-risk evaluation reports for global regulatory submissions.
This role involves end-to-end report lifecycle management, including planning, authoring, coordinating reviews, approvals, and submissions in compliance with international regulatory standards. The selected candidate will apply advanced pharmacovigilance and medical writing expertise to deliver high-quality, compliant documents while mentoring junior writers and supporting cross-functional project activities.
Experience Required
Minimum 4+ years of experience in the pharmaceutical industry
At least 3+ years of focused experience in medical writing or safety writing
Proven experience in authoring aggregate safety reports for regulatory submissions
Key Responsibilities
Author and review global regulatory safety documents, including:
Annual Reports (IND and others)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Addendum and ad hoc safety reports
Prepare and review Risk Management Plans (RMPs), signal reports, and safety issue analyses
Draft Common Technical Document (CTD) sections including Clinical Overviews, Clinical Summaries, and Non-Clinical Summaries
Perform and review signal detection activities and contribute to signaling strategies
Conduct safety database searches, literature reviews, and data analysis for signal evaluation
Draft responses to health authority queries and coordinate with cross-functional stakeholders
Create and update product labeling documents (Core Data Sheets, USPI, SPCs, Medication Guides) and justify label changes
Author manuscripts, abstracts, posters, and medical information responses
Develop and review SOPs, Work Instructions (WIs), and process documentation
Mentor junior writers through coaching, training sessions, and hands-on shadowing
Support resource estimation, RFP responses, and project management activities
Ensure regulatory compliance with global pharmacovigilance requirements, ICH guidelines, and GCP standards
Maintain quality metrics, perform document quality checks, and ensure timely deliverables
Required Qualifications
Bachelor’s degree in Life Sciences or related discipline (or equivalent experience)
Strong understanding of global regulatory requirements and pharmacovigilance practices
Knowledge of ICH GCP guidelines
Excellent written and spoken English
Strong organizational and time management skills
Proficiency in MS Office tools
Excellent interpersonal and communication skills
Preferred Qualifications
Advanced degree (Master’s or PhD) in Life Sciences or related field
Scientific or clinical research background
Experience in global labeling updates and regulatory interactions
Work Environment
Remote role based in Mumbai, India
Travel requirement: Up to 10%, including occasional overnight travel as required by project needs
Why Apply?
This is a strategic opportunity for experienced medical writers specializing in pharmacovigilance and regulatory safety reporting. The role offers exposure to global regulatory submissions, signal detection strategies, and benefit-risk evaluation documentation within a dynamic pharmaceutical or CRO environment.
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