Fortrea, a global leader in contract research, is seeking a Principal Safety Writer in Mumbai, India. If you are passionate about clinical development and regulatory writing, this is an excellent opportunity to join a cutting-edge organization transforming drug and medical device development.
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing comprehensive clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a workforce of 19,000 employees across more than 90 countries, Fortrea is committed to delivering innovative solutions to pharmaceutical, biotechnology, and medical device companies. Their mission is to accelerate the delivery of life-saving therapies to patients worldwide.
Key Responsibilities
As a Principal Safety Writer, you will:
- Write and review various safety reports for global regulatory submissions, such as Annual Reports (IND and others), Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Medical Device Reports, and more.
- Lead the full process of report production, ensuring quality standards and timelines are met. Provide oversight to co-authors or teams of writers and ensure accountability for their contributions.
- Act as the primary point of contact for clients, managing report-related activities and addressing any challenges or escalations.
- Author/review Risk Management Plans (RMPs), Benefit-Risk Evaluation reports, and reports for risk minimization measures and pharmacovigilance activities.
- Participate in signal management processes, collaborating on safety analysis and proposing risk mitigation measures when needed.
- Draft responses to health authority questions and work with cross-functional teams on feedback management.
- Develop scientific publications, such as abstracts, posters, manuscripts, and medical information responses for healthcare professionals.
- Act as a writing coach, providing feedback, conducting training, and sharing best practices with team members.
- Contribute to business development by estimating resource requirements and responding to requests for proposals (RFPs).
- Ensure compliance with regulatory standards and internal procedures while maintaining a high level of customer service.
Qualifications and Skills
- Experience in regulatory writing, safety reporting, and working with regulatory bodies.
- Strong leadership and client management skills, with the ability to lead and mentor teams.
- Knowledge of safety databases, regulatory guidelines, and signal management processes.
- Excellent writing and communication skills with experience in scientific writing and safety reporting.
