Principal Safety Writer – Clinical
Location: Mumbai, India
Company: Fortrea
Work Mode: Hybrid
Job Summary
Fortrea, a global contract research organization (CRO), is seeking a highly skilled Principal Safety Writer to lead the development of aggregate safety reports, risk management plans, signal detection, and benefit-risk evaluation reports. This role requires expertise in medical writing and regulatory documentation within the pharmaceutical and clinical research sector. You will independently manage safety deliverables involving complex data analyses and provide technical guidance to writing teams, ensuring high-quality scientific content in compliance with global regulatory requirements.
Key Responsibilities
Author and review safety reports for global regulatory submissions, including Annual Reports (IND and others), PSURs, PADERs, DSURs, Clinical Overviews, and Medical Device reports.
Lead report production processes ensuring quality standards and timelines are met.
Oversee writing teams and review co-author contributions.
Act as the primary client contact for report management activities and communications.
Develop RMPs, benefit-risk evaluations, safety issue analyses, and signal evaluation reports.
Participate in signal management processes and safety/benefit-risk review meetings.
Draft responses to health authority feedback and collaborate with cross-functional teams.
Contribute to scientific publications, abstracts, posters, and manuscripts.
Coach and mentor team members on writing quality and best practices.
Support project management activities such as schedule maintenance and compliance tracking.
Assist in business development, including resource estimation and RFP responses.
Conduct comprehensive literature reviews and complex data searches.
Ensure regulatory compliance and quality deliverables in line with SOPs.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences or equivalent; advanced degree (PhD or Master’s) preferred.
Minimum 5-7 years of pharmaceutical industry experience with at least 4 years in medical writing.
Strong knowledge of global regulatory requirements, GVP, ICH-GCP guidelines.
Expertise in aggregate reporting, signal management, and pharmacovigilance practices.
Proficient in MS Office and scientific literature searches.
Excellent written and verbal communication skills in English.
Proven organizational, time management, leadership, and interpersonal skills.
Ability to work independently and coach team members.
Perks & Benefits
Hybrid work flexibility.
Global exposure working with cross-functional teams.
Opportunity to contribute to scientific publications and regulatory strategy.
Access to training programs for skill enhancement.
Career advancement opportunities within a top global CRO.
Company Overview
Fortrea is a global contract research organization (CRO) serving pharmaceutical, biotechnology, and medical device industries. Operating in over 100 countries, Fortrea provides clinical development and technology solutions across 20+ therapeutic areas. Known for its scientific rigor and innovation, Fortrea is committed to advancing drug and device development to improve patient outcomes worldwide.
Call to Action
If you are an experienced medical writer with strong expertise in pharmacovigilance and regulatory writing, we invite you to apply today and contribute to impactful global drug safety initiatives.
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