Senior Safety Writer – Pharmacovigilance & Aggregate Safety Reporting
Location: Mumbai, India
Category: Clinical / Pharmacovigilance
Job ID: 256140
Employment Type: Full-Time
Experience Required: Minimum 4 years in the pharmaceutical industry, including at least 3 years in medical or safety writing
ThePharmaDaily.com is featuring an opportunity for an experienced Senior Safety Writer to join a leading global clinical research organization. This role is ideal for pharmacovigilance and medical writing professionals with strong expertise in aggregate safety reporting, risk management documentation, signal detection, and regulatory submissions.
This position plays a strategic role in end-to-end safety report development, regulatory compliance, and benefit-risk evaluation across global clinical and post-marketing programs.
Role Overview
The Senior Safety Writer leads the preparation, review, and lifecycle management of aggregate safety documents and risk management reports. The role involves planning, authoring, coordinating cross-functional reviews, ensuring regulatory compliance, and delivering high-quality submissions within defined timelines.
You will also mentor junior writers, contribute to process improvement initiatives, and collaborate with global stakeholders to ensure accurate and timely safety communication.
Key Responsibilities
Aggregate Safety & Regulatory Reporting
Author and review aggregate safety reports for global regulatory submissions, including:
Annual Reports (IND and other regional formats)
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
Develop and review Risk Management Plans (RMPs) and medical device safety reports
Prepare Common Technical Document (CTD) summaries including Clinical and Non-Clinical Overviews
Draft responses to health authority queries and coordinate follow-up with cross-functional teams
Signal Detection & Risk Evaluation
Perform and review signal detection activities
Conduct literature searches and database reviews for safety signal evaluation
Author signal reports and safety issue analysis reports
Participate in safety review meetings and contribute to signaling strategies
Labeling & Safety Documentation
Create and update labeling documents including Core Data Sheets, US Prescribing Information (USPI), Summary of Product Characteristics (SmPC/SPC), and Medication Guides
Author proposed label changes and prepare supporting justification documentation
Scientific Communication & Publications
Author and review manuscripts, abstracts, and posters for scientific conferences
Prepare medical information responses for healthcare professionals
Process Leadership & Mentorship
Coordinate report writing activities across writing teams
Maintain quality metrics and perform document quality checks
Develop or review SOPs, work instructions, and process documentation
Provide training, mentoring, and hands-on coaching to junior team members
Support project management, resource estimation, and RFP responses
Compliance & Quality
Ensure compliance with global pharmacovigilance regulations, ICH guidelines, and GCP standards
Promote consistent, efficient, and quality-driven processes
Maintain strong internal and client-facing communication
Educational Qualifications
Bachelor’s degree in Life Sciences or equivalent (mandatory)
Advanced degree (Master’s or PhD) preferred
Equivalent industry experience may be considered
Experience Required
Minimum 4 years of experience in the pharmaceutical industry
At least 3 years of hands-on experience in medical writing or safety writing
Demonstrated expertise in aggregate safety reporting and regulatory documentation
Strong knowledge of pharmacovigilance practices, ICH guidelines, and global regulatory requirements
Key Skills & Competencies
Excellent written and spoken English
Strong understanding of benefit-risk evaluation and global safety reporting requirements
Experience with MS Office and safety documentation systems
Strong organizational and time management skills
Ability to manage multiple deliverables with strict timelines
Effective interpersonal and client communication skills
Ability to work independently and collaboratively in cross-functional teams
Work Environment
Based in Mumbai
Travel up to 10% may be required depending on project needs
Why This Role Is Strategic
Senior Safety Writers are critical to global drug development and lifecycle safety management. This role directly supports regulatory compliance, risk minimization strategies, labeling updates, and global pharmacovigilance obligations.
Professionals seeking career advancement in pharmacovigilance writing, regulatory safety documentation, benefit-risk assessment, aggregate safety reporting, and signal detection will find this opportunity aligned with long-term growth in clinical research and pharmaceutical safety operations.
Discover More
Explore additional global careers in pharmacovigilance, drug safety, regulatory affairs, and clinical research at ThePharmaDaily.com.
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