Fortrea, a global leader in clinical development and pharmacovigilance services, is hiring a Senior Safety Writer and Project Coordinator for its Mumbai (Hybrid) location. This is a high-impact opportunity for experienced medical and safety writers to lead aggregate safety reporting, benefit-risk evaluations, and regulatory submissions for global clients.
If you have strong expertise in pharmacovigilance, ICH guidelines, aggregate reports, and project coordination, this role offers career growth, leadership exposure, and client-facing responsibilities in a global environment.
🔍 Job Overview
As a Senior Safety Writer & Project Coordinator, you will be responsible for end-to-end management of safety and regulatory documents, including planning, authoring, review coordination, approvals, and submissions. You will act as a primary client contact, mentor junior writers, and ensure timely, high-quality, and compliant deliverables.
This role combines hands-on safety writing with project coordination and stakeholder management, making it ideal for professionals seeking leadership roles in drug safety and regulatory medical writing.
🧾 Key Responsibilities
- Lead preparation and review of aggregate safety reports, including:
- PSUR / PBRER
- DSUR
- PADER
- Annual Reports (IND and others)
- Benefit-Risk Evaluation and Signal Detection Reports
- Author and review Risk Management Plans (RMPs), addendum reports, safety update reports, and ad hoc regulatory documents
- Write CTD summaries, including:
- Clinical Overviews
- Non-Clinical Overviews
- Clinical Summaries
- Generate and review line listings, summary tabulations, CFIs, and CFCs
- Create and update product labeling documents:
- Core Data Sheets (CDS)
- USPI
- SmPC / SPC
- Medication Guides
- Conduct scientific literature searches, recommend label changes, and prepare justification documents
- Prepare medical information responses for healthcare professionals (HCPs)
- Coordinate activities across a team of medical/safety writers, including:
- Resource allocation
- Timelines and tracking
- Cross-functional communication
- Act as primary client liaison for safety writing deliverables
- Perform quality checks, maintain metrics, and support audits
- Assist with resource estimation and RFP responses
- Mentor junior writers and act as a writing coach
- Ensure compliance with global regulatory requirements, SOPs, and pharmacovigilance standards
🎓 Qualifications & Experience
Minimum Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field
- 5–7 years of experience in the pharmaceutical industry
or - Minimum 4 years of experience in medical/safety writing
- Strong knowledge of:
- Pharmacovigilance regulations
- ICH guidelines
- Benefit-risk assessment
- Aggregate safety reporting
Preferred Qualifications
- Master’s degree or PhD (Life Sciences / Pharmacy / Medicine)
- Experience in drug discovery and pharmacovigilance
- Scientific or clinical research background
🧠 Skills Required
- Excellent written and spoken English
- Strong regulatory and safety writing expertise
- Proficiency in MS Office
- Outstanding organizational and time-management skills
- Strong interpersonal and client-communication abilities
- Deep understanding of:
- Anatomy and physiology
- Disease states and medical treatments
- Drug safety lifecycle and risk management
💼 Benefits & Work Environment
- Competitive salary package
- Hybrid work model (office + home-based)
- Exposure to global regulatory submissions
- Leadership and mentoring opportunities
- Work with international sponsors and cross-functional teams
- Travel requirement limited to ~10%, project-dependent
- Inclusive workplace with EEO and accommodations support
📍 Job Location
Mumbai, Maharashtra, India (Hybrid)
💰 Salary (Estimated)
₹18,00,000 – ₹28,00,000 per annum
(Based on experience, role scope, and industry benchmarks)
