We are seeking a highly motivated and detail-oriented Senior Safety Writer and Project Coordinator to join our team. As a key member of our team, you will play a critical role in leading the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports.
🏢About the Role
Job Title: Senior Safety Writer and Project Coordinator
Employment Type: Full-time, Hybrid
Location: Pune (with some travel requirements)
Experience: 5-7 years in medical writing, pharmacovigilance, or a related field
🔍Responsibilities
Report Management: Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports, ensuring timely delivery and high-quality documents.
Project Coordination: Coordinate activities related to report writing across a team of writers, including schedule oversight, team allocations, and communication with different teams for data.
Medical Writing: Write and review various safety reports, including Annual Reports, Periodic Safety Update Reports, and Clinical Study Reports.
Collaboration: Foster excellent working relationships with internal and external clients, cost-effectively providing high-quality service.
Quality Assurance: Perform quality checks and document reviews to ensure accuracy and compliance with regulatory requirements.
🎓Requirements
Education: Minimum of a first degree in life sciences (or equivalent), with an advanced degree (e.g., PhD or Master’s) preferred.
Experience: At least 5-7 years of experience in medical writing, pharmacovigilance, or a related field, with a strong understanding of regulatory requirements and pharmacovigilance practices.
Skills:
Excellent command of written and spoken English.
Strong organisational and time management abilities.
Proficiency in MS Office.
Good understanding of anatomy, physiology, treatments, and procedures.
💰What We Offer
Competitive Salary: A competitive salary package with benefits.
Career Growth: Opportunities for professional growth and development within a leading organisation.
Collaborative Environment: A dynamic and supportive team environment that encourages innovation and creativity.
📩 Ready to Apply?
If you’re a motivated and detail-oriented professional seeking an exciting career in medical writing and project coordination, we’d love to hear from you! 👉🏻 Apply Now:
🔗 Senior Safety Writer and Project Coordinator – Fortrea (Pune)