Senior Safety Writer – Fortrea, Pune

Fortrea is seeking a Senior Safety Writer to join their Pune team in a hybrid role. This full-time position involves leading the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. The ideal candidate will manage end-to-end report processes, mentor junior writers, and ensure timely delivery of high-quality documents.

📝 Key Responsibilities

• Report Writing & Review: Author and review various safety reports for global regulatory submissions, including Annual Reports (IND), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
• Signal Detection & Safety Analysis: Conduct signal detection activities, prepare signal reports, and perform safety issue analysis.
• Mentorship & Training: Coach and mentor junior medical writers, providing training and hands-on experience.
• Regulatory Compliance: Ensure compliance with regulatory requirements and good pharmacovigilance practices.
• Client Communication: Collaborate with internal and external stakeholders to gather necessary inputs and resolve issues affecting project deliverables.

🎓 Qualifications

• Education: Minimum of a first degree in life sciences or equivalent.
• Experience: At least 4 years in the pharmaceutical industry, with a minimum of 3 years in medical writing.
• Skills: Excellent command of written and spoken English, proficiency in MS Office, strong organizational and time management abilities, and excellent interpersonal skills.
• Knowledge: Good understanding of regulatory requirements, good pharmacovigilance practices, and ICH GCP guidelines.

💼 Preferred Qualifications

• Advanced Degree: PhD or Masters in a relevant field.
• Scientific or Clinical Research Experience: Desirable but not mandatory.

🌟 Benefits

• Work Environment: Hybrid model with flexibility.
• Professional Growth: Opportunities for training and development.
• Team Collaboration: Work with a global team of experts in the field.

📅 Application Instructions

Application Link