Looking to build a strong career in pharmacovigilance and drug safety? A leading global CRO is hiring a Safety Science Coordinator I in Pune, offering an excellent opportunity for professionals with experience in AE/SAE case processing, MedDRA coding, and regulatory submissions.
This role is ideal for candidates with a background in B.Pharm, M.Pharm, or Pharm.D and hands-on experience in clinical safety operations, especially within clinical trials or post-marketing surveillance.
🔍 Job Overview
The Safety Science Coordinator will support clinical safety and pharmacovigilance (PV) operations, including end-to-end handling of adverse events (AEs) and serious adverse events (SAEs). The role involves ensuring timely regulatory reporting, high-quality data processing, and compliance with global safety standards.
🧪 Key Responsibilities
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
- Perform AE/SAE case intake, data entry, and tracking in safety databases
- Write accurate patient narratives and perform MedDRA coding
- Conduct listedness assessment for marketed products
- Generate and manage queries for missing or inconsistent safety data
- Ensure timely submission of SAE reports to regulatory authorities, clients, and ethics committees
- Maintain adverse event tracking systems and documentation files
- Support quality review and reconciliation of safety databases
- Assist in regulatory compliance and audit readiness
- Collaborate with cross-functional teams and mentor junior staff
- Work within SOPs, WIs, and Quality Management Systems (QMS)
🎓 Qualifications & Eligibility
Educational Requirements:
- B.Pharm / M.Pharm / Pharm.D / Life Sciences / Nursing / Medical Sciences
Experience Required:
- Minimum 2+ years in pharmacovigilance or clinical safety
- Hands-on experience in:
- AE/SAE case processing
- Narrative writing
- MedDRA coding
- Safety databases (Argus, ARISg, etc.)
- Regulatory submissions
Preferred Skills:
- Strong attention to detail and data accuracy
- Ability to handle multiple safety cases under tight timelines
- Good communication and documentation skills
- Proficiency in MS Office tools
💼 Benefits & Work Environment
- Opportunity to work in a global CRO environment
- Exposure to international regulatory guidelines and PV systems
- Career growth in drug safety, risk management, and clinical research
- Collaborative and compliance-driven work culture
- Office-based role in Pune
💰 Salary Insight (India Market Estimate)
- Expected Salary Range: ₹4.5 LPA – ₹7.5 LPA
(Based on experience, PV skills, and database expertise)
📍 Job Location
- Pune, Maharashtra, India
📅 Important Dates
- Date Posted: April 3, 2026
- Last Date to Apply: April 8, 2026
🚀 How to Apply
