Fortrea is hiring a Safety Science Coordinator I in Pune (Hybrid). This full-time position offers an excellent opportunity for pharmacy and life science graduates to advance their careers in pharmacovigilance, clinical safety, and drug safety operations.
If you’re passionate about adverse event (AE/SAE) processing, safety reporting, and regulatory submissions, this role provides hands-on exposure with global clients while working in a collaborative environment.
Key Responsibilities
As a Safety Science Coordinator I, you will:
- Assist in processing Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), and submissions to clients and regulatory authorities.
- Maintain adverse event tracking systems and ensure accurate data entry.
- Write patient narratives, code AEs using MedDRA, and assess listedness for marketed products.
- Generate queries for missing/discrepant safety data and liaise with medical staff.
- Submit expedited SAE reports to clients, ECs, investigators, partners, and vendors.
- Support peer/quality review of safety reports and database reconciliation.
- Assist in archiving study safety files and arranging internal/external meetings.
- Train and mentor PSS Assistants and collaborate across functional units.
- Ensure compliance with SOPs, WIs, and regulatory requirements.
Required Qualifications
- Education: PharmD / M.Pharm / B.Pharm (preferred in Pharmacy, Nursing, Medical Sciences, Life Sciences).
- Experience: Minimum 1 year in pharmacovigilance, clinical safety, clinical data management, regulatory affairs, or related roles.
- Hands-on experience with AE/SAE case processing, narrative writing, safety databases, and regulatory submissions.
- Proficiency in English (speaking, reading, and writing).
- Strong attention to detail, logical reasoning, and excellent communication skills.
- Computer proficiency with MS Office; ability to manage multiple tasks effectively.
Benefits of Joining Fortrea
- Opportunity to work in a global CRO environment.
- Hybrid work model with flexibility.
- Exposure to drug safety regulations and compliance standards.
- Skill development through mentoring and training opportunities.
- Competitive salary and career progression in pharmacovigilance and safety science.
How to Apply
