Safety Science Coordinator I & II Openings at Fortrea

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:

1. Safety Science Coordinator I 
2. 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