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Fortrea, a leading global CRO, is inviting applications for the Safety Science Coordinator I role in Pune, India.
This position is ideal for life science, pharmacy, or nursing graduates aspiring to build a career in pharmacovigilance, clinical safety, and drug development. Candidates will assist in processing adverse event reports, maintaining safety databases, and supporting regulatory submissions — a perfect launchpad for your clinical safety career.
🧩 Key Responsibilities
As a Safety Science Coordinator I at Fortrea, you will:
- Assist in the processing of Expedited and Periodic Safety Reports (ESRs, PSRs).
- Maintain adverse event tracking systems and safety documentation.
- Perform data entry of safety data and code AEs using MedDRA.
- Draft and review patient narratives and perform listedness assessments.
- Support regulatory submissions and reconciliation of safety databases.
- Coordinate with internal teams, clients, and regulatory authorities.
- Adhere to GxP, SOPs, and Quality Management System requirements.
- Mentor junior PSS Assistants and participate in cross-functional meetings.
🎓 Qualifications & Experience
- Education:
- B.Sc./B.Pharm./M.Sc./M.Pharm./Pharm.D. in Life Sciences, Pharmacy, Nursing, or related fields.
- Experience:
- 0–1 year of experience in pharmacovigilance, clinical safety, clinical data management, or regulatory affairs.
- Skills Required:
- Excellent communication, attention to detail, and MS Office proficiency.
- Familiarity with MedDRA coding, adverse event reporting, and data quality review.
- Team player with strong analytical and documentation skills.
💼 Why Join Fortrea
- Work with a global leader in clinical research and pharmacovigilance.
- Opportunity to gain exposure to global regulatory processes.
- Collaborative and supportive work environment.
- Competitive salary and professional growth opportunities.
📅 Application Details
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