Job Title: Senior Safety Writer – Aggregate Reports & Pharmacovigilance
Location: Mumbai, Maharashtra, India
Job Category: Clinical / Drug Safety
Job ID: 2694
Company: Fortrea
Job Overview
Fortrea is seeking a Senior Safety Writer to lead the preparation, review, and lifecycle management of aggregate safety reports, risk management documents, signal detection analyses, and benefit-risk evaluations for global regulatory submissions.
This role is responsible for end-to-end medical writing activities, including planning, authoring, coordinating reviews, approvals, and regulatory submissions in compliance with international pharmacovigilance and clinical research standards. The position also includes mentoring junior writers, supporting project management activities, and maintaining strong client relationships.
The ideal candidate brings strong regulatory writing expertise, pharmacovigilance knowledge, and experience handling medium to high complexity safety deliverables.
Key Responsibilities
Author and review aggregate safety reports for global regulatory submissions including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Annual Reports (IND and others)
Addendum and ad hoc safety reports
Prepare and review Risk Management Plans (RMPs), medical device safety reports, and benefit-risk evaluations
Draft Common Technical Document (CTD) summaries including Clinical Overviews, Clinical Summaries, and Non-Clinical Overviews
Lead signal detection and safety issue analyses, including literature searches and database reviews
Author signal evaluation reports and participate in safety review meetings
Draft regulatory authority responses and collaborate cross-functionally to address health authority queries
Prepare manuscripts, abstracts, conference posters, and medical information responses for healthcare professionals
Create and update product labeling documents such as Core Data Sheets, USPI, Summary of Product Characteristics (SmPC), and Medication Guides
Conduct literature reviews and evaluate safety data from internal and external sources
Coordinate report writing activities across writing teams where applicable
Support resource estimation and RFP responses
Perform quality checks, metrics tracking, and compliance documentation
Author and review SOPs, Work Instructions, and process documentation
Coach and mentor junior writers; design and deliver training programs
Ensure all deliverables comply with global regulatory requirements and pharmacovigilance standards
Educational Qualification
Bachelor’s degree in Life Sciences or equivalent
Advanced degree (Master’s or PhD) preferred
Equivalent relevant experience may be considered
Experience Required
Minimum 4 years of experience in the pharmaceutical industry
At least 3 years of experience in medical writing, preferably in pharmacovigilance or safety writing
Strong understanding of global regulatory requirements, Good Pharmacovigilance Practices (GVP), and ICH-GCP guidelines
Experience authoring aggregate safety reports and regulatory submissions
Scientific or clinical research experience desirable
Core Competencies
Excellent written and spoken English communication skills
Strong knowledge of MS Office and document management tools
Advanced organizational and time management skills
Ability to manage multiple complex deliverables within strict timelines
Strong interpersonal and stakeholder communication skills
Detail-oriented with high commitment to quality and compliance
Work Environment & Travel
Based in Mumbai, India
Up to 10% travel may be required, including overnight stays, based on project needs
Why Join Fortrea?
Fortrea is a leading global CRO delivering clinical development and post-marketing safety solutions to pharmaceutical and biotechnology sponsors worldwide. The organization emphasizes regulatory excellence, scientific rigor, and patient safety across therapeutic areas.
This position offers:
Leadership opportunities in global pharmacovigilance writing
Exposure to international regulatory agencies and submission frameworks
Mentorship and team development responsibilities
Career advancement within clinical safety and regulatory writing
Fortrea is an Equal Opportunity Employer committed to inclusive hiring practices and regulatory-compliant operations.
This job listing is optimized for search visibility in Senior Safety Writer, Pharmacovigilance Medical Writing, Aggregate Safety Reporting, Risk Management Plans, Signal Detection, and Regulatory Medical Writing careers in India and global markets on ThePharmaDaily.com.
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