Fortrea Hiring Aggregate Report Writing Team | Principal Safety Writer | WFH

Fortrea, a leading global contract research organization (CRO), is actively hiring for its Aggregate Report Writing Team. With positions open in Pune, Mumbai, and remote, Fortrea offers an exciting opportunity for professionals with a passion for safety writing and pharmacovigilance. If you have 2+ years of experience in writing and reviewing safety reports and are ready to make a global impact, this could be the role for you!

About Fortrea

Fortrea is a trusted global leader in clinical research and development, working across more than 90 countries and covering over 20 therapeutic areas. With a strong commitment to scientific rigor and innovation, Fortrea supports pharmaceutical, biotechnology, and medical device companies in bringing life-changing therapies to patients worldwide. As part of Fortrea’s mission, the Aggregate Report Writing Team plays a critical role in ensuring compliance with global safety regulations, providing high-quality safety reports that meet international standards.

Job Role: Principal Safety Writer

Position:

Principal Safety Writer – Aggregate Report Writing Team

Locations:

• Pune, Maharashtra
• Mumbai, Maharashtra
• Home-based (Remote)

Job Type:

• Full-time, Permanent

Key Qualifications:

• Minimum 2 years of experience in end-to-end writing and reviewing safety reports for regulatory submissions.
• Background in pharmacovigilance, clinical safety, or related fields.
• Strong understanding of global regulatory requirements for safety documentation.

Preferred Qualifications:

• Experience with Aggregate Reports such as:
  • Periodic Safety Update Reports (PSUR)
  • Development Safety Update Reports (DSUR)
  • Periodic Adverse Drug Experience Reports (PADER)
  • Annual Reports (IND and others)

Key Responsibilities

As a Principal Safety Writer at Fortrea, you will:

1. Write and review safety reports for submission to regulatory authorities across the globe. These include Annual Reports, Periodic Safety Update Reports, Adverse Drug Experience Reports, and Development Safety Update Reports.
2. Lead the end-to-end report production process, ensuring that deadlines and quality standards are met.
3. Serve as the primary client contact, managing expectations and addressing challenges related to report management.
4. Collaborate with safety physicians and participate in benefit-risk evaluations.
5. Author safety reports and signals using data from safety databases, scientific literature, and other sources.
6. Mentor junior writers, providing guidance and promoting best practices in safety writing.
7. Assist in the development of labeling documents and contribute to signal management processes.
8. Participate in safety review meetings with clients and regulatory authorities.
9. Draft responses to health authority queries and collaborate with cross-functional teams to manage regulatory feedback.

Apply online at Fortrea Careers