Safety Writer Job in Mumbai – Apply Now

Are you an experienced Safety Writer looking to advance your career in the pharmaceutical industry? Fortrea is hiring a full-time Safety Writer in Mumbai. This role offers the opportunity to work on aggregate safety reports, risk management plans, and regulatory submissions while collaborating with global teams. If you have a passion for medical writing, pharmacovigilance, and regulatory compliance, this could be your next career move.

📝 Key Responsibilities

As a Safety Writer, you will:

• Prepare and review safety reports for global regulatory submissions (Annual Reports, DSURs, PSURs, PADERs, RMPs).
• Lead report planning activities, including data collection, kick-off meetings, and comment resolution discussions.
• Perform quality review of reports drafted by junior writers and provide constructive feedback.
• Contribute to ad-hoc reports, benefit-risk evaluation documents, and label update justifications.
• Write CTD Summaries (non-clinical and clinical), clinical summaries, and regulatory documents.
• Draft adverse event narratives and medical information responses for healthcare professionals.
• Support signal detection and safety issue analysis reports.
• Conduct literature searches, review strategies, and summarize findings.
• Collaborate with cross-functional teams and clients to ensure timely, high-quality deliverables.
• Ensure compliance with ICH-GCP, pharmacovigilance practices, and regulatory requirements.

🎓 Qualifications

Minimum Requirements:

• Bachelor’s degree in Life Sciences or equivalent.
• Minimum 3 years of pharmaceutical industry experience (at least 2 years in medical writing).
• Strong command of written and spoken English.
• Excellent organizational, communication, and time-management skills.
• Knowledge of MS Office, regulatory requirements, and pharmacovigilance practices.

Preferred Qualifications:

• Advanced degree (M.Sc., M.Pharm, or PhD).
• Clinical research or scientific writing background.
• Familiarity with safety data analysis and regulatory submissions.

🌟 Benefits of Joining

• Opportunity to work on global regulatory safety submissions.
• Gain experience with complex safety and risk management documents.
• Exposure to cross-functional teams and international clients.
• Supportive work culture with training opportunities.
• Competitive salary and benefits package.
• Limited travel (up to 5%).

📌 Application Process

Application Link