Fortrea, a leading global contract research organization (CRO), is inviting applications for the role of Safety Science Coordinator II at its Pune location. This is a full-time opportunity for pharmacovigilance professionals with experience in clinical safety, adverse event processing, and regulatory reporting. The role supports both clinical trial and post-marketing safety operations, ensuring compliance with global regulatory timelines and quality standards.
This position is ideal for candidates seeking career growth in drug safety, pharmacovigilance operations, SAE processing, and regulatory submissions within a global CRO environment.
Job Overview – Safety Science Coordinator II
As a Safety Science Coordinator II, you will assist in end-to-end Clinical Safety and Pharmacovigilance (PV) operations, including adverse event (AE) case processing, expedited reporting, database reconciliation, and regulatory submissions. The role requires strong knowledge of ICH-GCP, MedDRA coding, SAE reporting timelines, and client-specific safety management plans.
Key Responsibilities
- Process adverse event (AE) and serious adverse event (SAE) reports from clinical trials and post-marketing sources
- Perform data entry and case processing in safety databases and tracking systems
- Review cases for completeness, accuracy, and regulatory compliance
- Prepare patient narratives and code AEs using MedDRA
- Identify missing clinical information and generate follow-up queries
- Ensure cases receive medical review where required
- Manage expedited reporting to global regulatory authorities within timelines
- Submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
- Maintain project files, central documentation, and tracking logs
- Support quality review, peer review, and database reconciliation activities
- Assist in audits, inspections, and quality issue management
- Mentor junior PSS staff and support training activities
- Contribute to monthly status reports and pharmacovigilance metrics
- Ensure compliance with SOPs, work instructions, and regulatory guidelines
Qualifications & Skills
- Degree in Pharmacy, Life Sciences, Nursing, or related discipline
- Experience in pharmacovigilance, drug safety, or clinical safety operations
- Strong understanding of SAE reporting, MedDRA coding, and regulatory timelines
- Familiarity with ICH, GCP, and global PV regulations
- Proficiency in MS Office and safety databases
- Ability to work independently with moderate supervision
- Strong attention to detail, documentation, and communication skills
- Mentoring and team-support skills preferred
Salary & Benefits
- Estimated Salary: ₹6,00,000 – ₹9,00,000 per annum (INR), based on experience
- Full-time employment with a global CRO
- Exposure to global pharmacovigilance projects
- Professional development and training opportunities
- Supportive work environment with quality-driven culture
Job Location
📍 Pune, Maharashtra, India
Application Process
