Fortrea is a leading global Contract Research Organization (CRO) providing comprehensive clinical development and commercialization services to pharmaceutical, biotechnology, and medical device companies. With a strong focus on patient safety and regulatory compliance, Fortrea plays a crucial role in drug safety monitoring and pharmacovigilance.
Job Openings: Safety Science Coordinator I & II
Fortrea is expanding its Pharmacovigilance & Safety Services (PSS) team in Pune and is looking for skilled professionals to join as:
- Safety Science Coordinator I
- Safety Science Coordinator II
📍 Location: Pune (Hybrid)
🕒 Job Type: Full-time
Detailed Job Description
Key Responsibilities:
✔ Process & manage adverse event (AE/SAE) reports from clinical trials & post-marketing sources.
✔ Ensure timely submission of Expedited Safety Reports (ESRs) & Periodic Safety Reports (PSRs) to regulatory authorities.
✔ Data entry & quality checks in safety databases, MedDRA coding, and narrative writing.
✔ Regulatory compliance with ICH-GCP, FDA, EMA, and other pharmacovigilance guidelines.
✔ Collaborate with clients, investigators, and regulatory bodies for safety reporting.
✔ Support audits, inspections, and quality management systems (QMS).
✔ Train & mentor junior team members in pharmacovigilance processes.
Eligibility Criteria
For Safety Science Coordinator I:
- Education: PharmD / MPharm / BPharm + 0 year of relevant experience
(OR)
Life Sciences / Nursing / Medical degree with pharmacovigilance experience. - Experience:
- Safety data processing, AE/SAE case handling, MedDRA coding.
- Regulatory submissions & clinical data management (preferred).
For Safety Science Coordinator II:
- Non-degree + 1 year Safety exp. OR 3 years relevant exp.
- Associate degree + 1 year Safety exp. OR 2 years relevant exp.
- BS/BA/MS/MA/PharmD + 1 year relevant exp.
- Preferred fields: Pharmacy, Nursing, Life Sciences, Medical Sciences.
Benefits & Work Environment
✅ Hybrid work model (Office + Remote flexibility)
✅ Competitive salary & growth opportunities
✅ Exposure to global pharmacovigilance standards
✅ Training & mentorship programs
✅ Collaborative & safety-focused work culture
How to Apply
🔗 Safety Science Coordinator I → Apply Here
🔗 Safety Science Coordinator II → Apply Here
