Job Title: Safety Science Coordinator I & II
Location: Pune, India (Hybrid)
About Fortrea:
Fortrea is a leading global Contract Research Organization (CRO) that provides comprehensive clinical development and commercialization services to pharmaceutical, biotechnology, and medical device companies. We are committed to patient safety and regulatory compliance and play a crucial role in drug safety monitoring and pharmacovigilance. We are expanding our Pharmacovigilance & Safety Services (PSS) team in Pune and are seeking talented professionals to join us as Safety Science Coordinators.
Job Summary:
As a Safety Science Coordinator, you will be responsible for processing and managing adverse event reports from clinical trials and post-marketing sources. You will ensure the timely submission of safety reports to regulatory authorities, perform data entry and quality checks in safety databases, and contribute to the overall safety and compliance of our projects.
Responsibilities:
- Process and manage adverse event (AE/SAE) reports from clinical trials and post-marketing sources.
- Ensure the timely submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to regulatory authorities.
- Perform data entry and quality checks in safety databases.
- Perform MedDRA coding and write narratives for safety reports.
- Ensure 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 and mentor junior team members in pharmacovigilance processes (for Safety Science Coordinator II).
Requirements:
Safety Science Coordinator I:
- Education: PharmD / MPharm / BPharm + 0 years of relevant experience OR Life Sciences / Nursing / Medical degree with pharmacovigilance experience.
- Experience:
- Experience in safety data processing, AE/SAE case handling, and MedDRA coding.
- Experience in regulatory submissions and clinical data management is preferred.
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:
- Hybrid work model (Office + Remote flexibility)
- Competitive salary and growth opportunities
- Exposure to global pharmacovigilance standards
- Training and mentorship programs
- Collaborative and safety-focused work culture
How to Apply:
Interested candidates are encouraged to apply online through the following links:
- Safety Science Coordinator I: [Apply Here]
- Safety Science Coordinator II: [Apply Here]
We look forward to receiving your application!
