Fortrea Hiring for Senior Safety Writer / Project Coordinator in Pune. Lead pharmacovigilance reports, safety writing, and coordination projects.
Introduction
Are you a skilled medical or scientific writer looking to take your career to the next level in pharmacovigilance and regulatory affairs?
Here’s an excellent opportunity to join Fortrea, a global leader in clinical research and drug safety services. Fortrea is currently hiring a Senior Safety Writer and Project Coordinator for its Pune (Hybrid) office. Fortrea Hiring for Senior Safety Writer / Project Coordinator
This role is ideal for professionals with a background in life sciences, medical writing, or pharmacovigilance, who have strong command over safety report authoring and coordination of multi-level writing projects.
If you have at least 5–7 years of experience in the pharmaceutical industry, including 4 years in medical writing, this position can be your next major career milestone. Fortrea Hiring for Senior Safety Writer / Project Coordinator
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing comprehensive drug development, regulatory, and post-marketing services to top pharmaceutical and biotechnology companies.
With a presence in over 90 countries, Fortrea combines medical science, data-driven insights, and regulatory expertise to deliver innovative solutions that enhance patient safety and accelerate the availability of life-saving therapies. Fortrea Hiring for Senior Safety Writer / Project Coordinator
Fortrea’s core strengths lie in pharmacovigilance, clinical operations, medical writing, and risk management. The company fosters a collaborative work environment that empowers employees to grow both technically and professionally while contributing to a healthier, safer world. Fortrea Hiring for Senior Safety Writer / Project Coordinator
Position Details
- Job Title: Senior Safety Writer and Project Coordinator
- Company: Fortrea
- Location: Pune (Hybrid)
- Employment Type: Full-time, Permanent
- Job Requisition ID: 255078
- Application Deadline: October 20, 2025
- Industry Type: Clinical Research / Pharmacovigilance / Drug Safety
- Functional Area: Medical Writing and Safety Reporting
Job Overview
As a Senior Safety Writer and Project Coordinator, you will lead the preparation, writing, and review of global regulatory and safety reports in compliance with international standards.
This position involves end-to-end report management — from planning and authoring to coordinating cross-functional reviews and submissions. Fortrea Hiring for Senior Safety Writer / Project Coordinator
You will collaborate closely with internal teams and external clients, ensuring high-quality deliverables that meet both scientific and regulatory requirements.
Additionally, the role involves mentoring junior writers, coordinating report writing schedules, and supporting strategic documentation for drug safety and benefit-risk evaluations.
This is a hybrid role, giving you the flexibility to work both from home and the office while engaging with diverse global projects. Fortrea Hiring for Senior Safety Writer / Project Coordinator
Key Responsibilities
As a Senior Safety Writer and Project Coordinator at Fortrea, you will be responsible for multiple functions related to safety documentation, report coordination, and project leadership. Your key responsibilities include: Fortrea Hiring for Senior Safety Writer / Project Coordinator
1. Medical and Regulatory Writing
- Author, review, and finalize aggregate safety reports including:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Annual Reports (IND and Non-IND)
- Ad hoc Safety Reports, Risk Management Plans (RMPs), and Bridging Reports
- Prepare and review Common Technical Document (CTD) Summaries including Clinical and Non-Clinical Overviews.
- Contribute to signal detection analyses, safety summaries, and cumulative review reports.
- Prepare medical information responses for healthcare professionals (HCPs) based on product safety data.
2. Project Coordination and Leadership
- Coordinate multiple writing projects simultaneously across different teams and geographies.
- Develop timelines, allocate resources, and monitor progress to ensure project milestones are achieved.
- Communicate effectively with clients and stakeholders to gather data, clarify requirements, and deliver updates.
- Serve as a primary point of contact for clients regarding report writing deliverables.
- Facilitate internal and external review meetings, ensuring comments are consolidated and addressed promptly.
3. Quality and Compliance
- Ensure all deliverables comply with Good Pharmacovigilance Practices (GVP), ICH-GCP guidelines, and relevant regulatory authority requirements.
- Perform quality control (QC) and peer reviews to maintain consistency and scientific accuracy.
- Maintain high-quality standards while meeting strict deadlines for multiple submissions.
- Track and document project metrics, report deviations, and recommend corrective actions.
4. Training and Mentorship
- Act as a writing coach to junior medical writers.
- Provide feedback, technical training, and guidance to enhance their writing quality.
- Lead training sessions on regulatory writing best practices, data interpretation, and document preparation.
5. Literature Review and Labeling Support
- Conduct detailed literature searches to gather relevant safety data, case reports, and scientific publications.
- Recommend label changes and author supporting justification documents.
- Assist in updating Core Data Sheets, USPI, and SPCs (Summary of Product Characteristics).
6. Operational and Strategic Support
- Assist in resource estimation and Request for Proposal (RFP) responses.
- Coordinate between medical, regulatory, and data teams for integrated safety outputs.
- Identify process improvement opportunities and implement solutions for efficiency.
- Support audit preparation and participate in inspection readiness activities.
- Fortrea Hiring for Senior Safety Writer / Project Coordinator
Qualifications and Educational Background
Minimum Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or Medicine.
- Equivalent combination of education, training, and experience will be considered.
Preferred Qualification
- Master’s or Ph.D. in Life Sciences or a related discipline is highly desirable.
- Formal training or certification in Pharmacovigilance, Medical Writing, or Clinical Research will be an added advantage.
Experience Requirements
- Minimum 5–7 years of experience in the pharmaceutical or clinical research industry.
- At least 4 years of hands-on experience in medical writing and safety documentation.
- Prior experience in pharmacovigilance, regulatory submissions, or safety risk management is preferred.
- Experience in drug development lifecycle, safety database systems, and clinical document management tools.
Key Skills and Competencies
- Exceptional command of written and spoken English.
- Strong scientific knowledge of anatomy, physiology, pharmacology, and disease mechanisms.
- Comprehensive understanding of regulatory requirements such as ICH E2E, EMA, and FDA safety guidelines.
- Excellent organizational and time-management skills to handle multiple priorities.
- Proficiency in MS Word, Excel, PowerPoint, and literature search tools (e.g., PubMed, Embase).
- Strong interpersonal skills to collaborate effectively with clients and team members.
- Analytical thinking with attention to detail and commitment to quality.
- Self-motivated with the ability to work independently under minimal supervision.
- Fortrea Hiring for Senior Safety Writer / Project Coordinator
Preferred Attributes
- Advanced academic qualifications (Ph.D., Pharm.D., or MD).
- Prior experience as a Safety Writer Lead or Team Coordinator.
- Exposure to signal detection, benefit-risk evaluation, and aggregate safety reports.
- Experience working in a CRO or multinational pharmaceutical environment.
- Knowledge of MedDRA coding, safety data review, and post-marketing surveillance.
Work Environment
- Work Mode: Hybrid (Office + Remote)
- Office Location: Pune, Maharashtra
- Travel: Occasional travel (up to 10%) may be required for client meetings, training sessions, or audits.
- Work Schedule: Standard business hours, with flexibility based on project deadlines and client requirements.
Fortrea offers a modern and collaborative work environment that values innovation, inclusivity, and continuous learning. Employees are encouraged to contribute ideas and improve safety documentation processes while maintaining a strong work-life balance. Fortrea Hiring for Senior Safety Writer / Project Coordinator
Why Join Fortrea?
- Be part of a globally recognized CRO trusted by top pharmaceutical and biotech companies.
- Work on cutting-edge pharmacovigilance projects that impact global patient safety.
- Gain exposure to diverse therapeutic areas and regulatory frameworks.
- Opportunity to lead global safety documentation projects and coordinate cross-functional teams.
- Fortrea provides continuous learning and professional development programs to enhance your writing and leadership skills.
- A supportive environment with mentorship, recognition, and career growth opportunities.
- Fortrea Hiring for Senior Safety Writer / Project Coordinator
How to Apply
Interested candidates can apply directly through the Fortrea Careers Portal before October 20, 2025.
Ensure that your resume highlights your experience in medical writing, pharmacovigilance documentation, and regulatory submissions.
Final Thoughts
This is a remarkable opportunity for experienced medical writers and pharmacovigilance professionals to advance their careers with a reputable global organization. As a Senior Safety Writer and Project Coordinator at Fortrea, you’ll play a pivotal role in ensuring the safety and compliance of life-changing medicines. Fortrea Hiring for Senior Safety Writer / Project Coordinator
If you’re passionate about scientific communication, regulatory writing, and patient safety, this role offers the perfect platform to excel.
Apply now and join Fortrea’s mission to make healthcare safer, smarter, and more impactful. Fortrea Hiring for Senior Safety Writer / Project Coordinator
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