Safety Writer Vacancy at Fortrea

Safety Writer Vacancy – Life Sciences Graduates | Mumbai

Apply for Safety Writer position at Fortrea, Mumbai. Open for life sciences graduates with 3+ years’ experience in medical writing.

Are you an experienced medical writer passionate about patient safety and regulatory compliance? Fortrea, a global leader in clinical development, is hiring a Safety Writer in Mumbai. This role offers the opportunity to work on critical safety documentation, collaborate with cross-functional teams, and contribute to global regulatory submissions. If you are ready to make a meaningful impact in the healthcare and pharmaceutical sector, this could be your next career move.

Company Overview

Fortrea is a trusted name in the pharmaceutical, biotech, and clinical research industry, known for delivering end-to-end clinical development and post-approval solutions. With a strong emphasis on pharmacovigilance, regulatory writing, and clinical trial support, Fortrea empowers life sciences organizations to accelerate the delivery of safe and effective treatments to patients worldwide.

Our teams are driven by science, innovation, and a commitment to patient-centric healthcare solutions. Joining Fortrea means working in an environment that values expertise, collaboration, and continuous professional development.

Job Role & Responsibilities

As a Safety Writer at Fortrea, you will:

• Prepare and review aggregate safety reports, risk management documents, and signal detection reports.
• Lead client communication and manage timelines for assigned reports.
• Provide oversight, quality checks, and mentoring support to junior safety writers.
• Conduct literature searches, analyze findings, and incorporate insights into reports.
• Author various safety and regulatory documents including:
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Risk Management Plans (RMPs)
  • Clinical Study Summaries and CTD modules
• Prepare narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs).
• Collaborate with cross-functional teams and external stakeholders to ensure compliance with ICH-GCP, pharmacovigilance guidelines, and global regulations.
• Contribute to label updates, literature abstracts, and medical information documents.
• Promote efficient, high-quality processes to ensure on-time regulatory submissions.

Eligibility / Qualifications

Minimum Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry, Microbiology, Clinical Research, or related fields.
• At least 3 years of pharmaceutical industry experience, with 2+ years in medical or safety writing.
• Strong command over written and spoken English.
• Proficiency in MS Office tools.
• Excellent organizational and time management skills.
• Solid understanding of pharmacovigilance practices, ICH-GCP guidelines, and regulatory compliance.

Preferred Qualifications:

• Master’s or PhD in life sciences or related field.
• Prior experience in clinical research or scientific writing.
• Familiarity with signal detection, benefit-risk evaluation, and global regulatory frameworks.

Location & Work Environment

• Location: Mumbai, India
• Work Type: Full-time
• Travel: Up to 5% (domestic or international as project needs demand)
• Flexible, collaborative, and diverse work culture supporting employee well-being and career growth.

Application Process

Interested candidates can apply directly through the Fortrea careers portal:

👉 Apply Here

Apply before the closing date: September 26, 2025.

Don’t miss the chance to work with a global leader in safety writing and pharmacovigilance. Apply today to secure your spot!

FAQs

Q1. What qualifications are required for the Fortrea Safety Writer role?
A Bachelor’s degree in life sciences or related fields with at least 3 years of experience in pharma/medical writing.

Q2. Is prior clinical research experience mandatory?
It is desirable but not mandatory. Equivalent industry experience will be considered.

Q3. What types of reports will I be working on?
You will work on PSURs, DSURs, PADERs, RMPs, CTD summaries, and safety narratives.

Q4. Does the role require travel?
Yes, up to 5% of travel (domestic or international) may be required.

Q5. When is the application deadline?
Applications close on September 26, 2025.

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