Fortrea is hiring for the position of Specialist I – Clinical Safety in Bangalore. This is an excellent opportunity for candidates with experience in pharmacovigilance, adverse event (AE/SAE) processing, regulatory submissions, and clinical safety operations. If you have hands-on exposure to safety databases, narrative writing, MedDRA coding, and expedited reporting, this role offers strong career growth in global drug safety operations.
This Clinical Safety Specialist job in Bangalore is ideal for Pharmacy, Life Sciences, Nursing, and Medical Sciences graduates looking to advance their career in drug safety and pharmacovigilance within a CRO environment.
🔬 Job Overview – Specialist I (Clinical Safety)
The Specialist I will support Clinical Safety and Pharmacovigilance (PV) operations, including:
- Managing adverse event reports from clinical trials and post-marketing sources
- Processing expedited safety reports within regulatory timelines
- Handling SAE submissions to regulatory authorities and clients
- Supporting signal detection and periodic safety reporting
The role ensures compliance with ICH Guidelines, GCP standards, and global regulatory requirements.
🧪 Key Responsibilities
Adverse Event & SAE Processing
- Receive and process spontaneous and clinical trial adverse event reports
- Perform data entry in safety databases
- Write clear and accurate patient narratives
- Code adverse events using MedDRA
- Assess listedness against product labels
- Identify missing clinical information and follow up
Expedited Reporting & Regulatory Compliance
- Submit expedited SAE reports within regulatory timelines
- Report endpoints to clients, ethics committees, and regulatory authorities
- Prepare and submit ESRs (Expedited Safety Reports) and PSRs (Periodic Safety Reports)
- Assist in PSURs, DSURs, and Annual IND reports
Safety Operations & Quality
- Maintain adverse event tracking systems
- Conduct database reconciliations with Data Management teams
- Perform peer review and quality checks
- Support audits and regulatory inspections
- Participate in signal detection and trend analysis
- Contribute to CAPA and root cause analysis
🎓 Qualifications Required
Eligible educational backgrounds include:
- BS/BA (Life Sciences/Pharmacy/Nursing/Medical Sciences) + 1–2 years safety experience
- MS/MA + 1–2 years safety experience
- PharmD + 1–2 years safety experience (Residency/Fellowship considered relevant)
- Associate degree + safety experience
- Non-degree candidates with 4–5 years relevant experience may also be considered
Preferred Disciplines:
Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences.
💼 Required Experience & Skills
- Hands-on experience in AE/SAE case processing
- Narrative writing and MedDRA coding
- Experience with safety databases
- Knowledge of ICH guidelines and GCP
- Understanding of global regulatory reporting requirements
- Strong communication skills
- Attention to detail and accuracy
- Proficiency in MS Office
💰 Salary & Benefits (Estimated)
- Estimated Salary Range: ₹4,50,000 – ₹7,50,000 per annum (based on experience)
- Global CRO exposure
- Learning opportunities in regulatory safety reporting
- Career progression in pharmacovigilance
- Participation in signal detection and safety data review
📍 Job Location
Bangalore, India
Work Environment: Office-based
Travel Requirement: ~5% (as per project needs)
📝 How to Apply
