Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing healthcare through clinical trials, drug safety, and regulatory solutions. With a strong commitment to quality and innovation, Fortrea partners with pharmaceutical and biotech companies to bring life-changing therapies to patients worldwide.
Detailed Job Description
Position: Safety Science Coordinator I
📍 Location: Pune (Hybrid)
🕒 Job Type: Full-time
⏳ Application Deadline: July 7, 2025
Key Responsibilities:
✔ Expedited & Periodic Safety Reports: Assist in processing and submitting ESRs & PSRs to regulatory agencies.
✔ Adverse Event Management: Log, track, and process AE/SAE reports in compliance with regulatory standards.
✔ Data Entry & Documentation: Maintain safety databases, generate queries, and write patient narratives.
✔ Regulatory Compliance: Ensure adherence to global pharmacovigilance regulations (FDA, EMA, ICH-GCP).
✔ Quality Control: Peer-review safety reports and support database reconciliations.
✔ Training & Support: Mentor junior team members and collaborate across departments.
Eligibility & Qualifications
Minimum Required Education & Experience:
- Non-Degree: 1-2 years of safety/relevant experience
- Associate Degree: 6 months – 1 year of experience
- BS/BA, MS/MA, or PharmD: 0-6 months to 1 year of experience
Preferred Background:
- Degrees in: Biological Sciences, Pharmacy, Nursing, Medical Sciences, or related fields.
- Safety Experience: Handling AE/SAE reports, MedDRA coding, regulatory submissions.
- Relevant Experience: Clinical Data Management, Regulatory Affairs, or Pharma/Biotech roles.
Skills Required:
✅ Strong attention to detail
✅ Excellent communication (English + local language)
✅ Proficiency in MS Office & safety databases
✅ Ability to multitask & meet deadlines
Benefits & Work Environment
🌍 Hybrid Work Model (Office + Remote flexibility)
📈 Career Growth in a global CRO
🏥 Health & Safety Compliance (COSHH, EC Directives)
💼 Inclusive Workplace (EEO & Accommodations)
How to Apply
📅 Deadline: July 7, 2025 (Only 3 days left!)
