Location: Mumbai, India
Job Type: Full-Time
Company: Fortrea
Department: Pharmacovigilance / Medical Writing / Drug Safety
Experience Required: Minimum 4 Years in Pharmaceutical Industry OR 3+ Years in Medical Writing
Freshers Eligible: No
About the Company
Fortrea is a leading global Contract Research Organization (CRO) delivering clinical development, patient access, and technology-driven solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The organization supports innovation across drug development and regulatory compliance through advanced scientific and pharmacovigilance expertise.
Job Overview
Fortrea is hiring an experienced Sr. Safety Writer for its Mumbai office. This role is ideal for professionals with strong expertise in pharmacovigilance, aggregate safety reporting, regulatory medical writing, signal detection, and benefit-risk evaluation.
The selected candidate will lead end-to-end preparation, review, management, and submission of global safety and regulatory documents while collaborating with cross-functional stakeholders, clients, and regulatory teams. The role also involves mentoring junior medical writers and supporting strategic pharmacovigilance operations.
This opportunity is highly suitable for professionals looking to build a long-term career in Drug Safety Writing, Regulatory Affairs, Medical Writing, Aggregate Reporting, and Pharmacovigilance Operations.
Key Responsibilities
Aggregate Safety & Regulatory Writing
Author and review global aggregate safety reports including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Annual IND Reports
Addendum and Adhoc Safety Reports
Risk Management & Signal Detection
Prepare and review:
Risk Management Plans (RMPs)
Benefit-Risk Evaluation Reports
Signal Detection Reports
Safety Issue Analysis Reports
Participate in signal management meetings and safety review discussions with sponsors and clients
Regulatory & Scientific Documentation
Write and review:
Common Technical Document (CTD) summaries
Clinical Overviews
Clinical Summaries
Non-Clinical Summaries
Medical Device Safety Reports
Draft responses to health authority queries and regulatory feedback
Medical & Scientific Communication
Author manuscripts, scientific abstracts, posters, and conference materials
Prepare medical information responses for Healthcare Professionals (HCPs)
Conduct literature searches and safety surveillance reviews
Labeling & Compliance Activities
Create and update:
Core Data Sheets (CDS)
USPI Labels
SPCs
Medication Guides
Recommend label changes and prepare supporting justification documentation
Training & Leadership
Mentor junior writers and associates
Conduct internal training sessions and shadowing programs
Support SOP creation, process documentation, and quality compliance initiatives
Project & Stakeholder Management
Coordinate with internal teams, sponsors, clients, and cross-functional stakeholders
Support project timelines, resource planning, metrics tracking, and quality reviews
Ensure compliance with global pharmacovigilance regulations and ICH-GCP guidelines
Educational Qualifications
Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related field
Advanced qualifications such as Master’s Degree or PhD preferred
Experience Required
Minimum 4 years of experience in the pharmaceutical or CRO industry
OR
Minimum 3 years of relevant experience specifically in Medical Writing or Pharmacovigilance Writing
Required Skills
Strong expertise in Aggregate Reporting and Drug Safety Writing
Excellent command of written and spoken English
Knowledge of global pharmacovigilance regulations and ICH-GCP guidelines
Experience with safety databases, literature review, and regulatory documentation
Strong organizational, communication, and stakeholder management skills
Proficiency in Microsoft Office tools
Preferred Skills
Scientific research or clinical research background
Experience in Benefit-Risk Evaluation and Signal Management
Regulatory submission documentation expertise
Team mentoring and project coordination experience
Work Environment & Travel
Hybrid/Office-based role in Mumbai
Up to 10% travel may be required based on project needs
Who Should Apply?
This role is best suited for:
Pharmacovigilance professionals
Medical Writers
Aggregate Report Authors
Regulatory Writing Specialists
Drug Safety Scientists
Signal Detection Experts
Freshers are not eligible for this position due to the advanced scientific and regulatory writing expertise required.
Why This Opportunity Matters
Senior Safety Writers are among the most in-demand professionals in the global pharmaceutical and CRO industry. With increasing global regulatory scrutiny and growing pharmacovigilance requirements, expertise in aggregate reporting, risk management, and safety evaluation offers excellent long-term career growth opportunities across multinational pharmaceutical companies and CROs.
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