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Fortrea has announced a new opening for an experienced Safety Science Specialist in Bangalore, offering an excellent opportunity for professionals with strong pharmacovigilance (PV) and clinical safety case processing experience. This role is ideal for candidates skilled in SAE reporting, narrative writing, MedDRA coding, safety databases, and end-to-end adverse event management.
If you’re looking for a career-defining opportunity in clinical safety operations, this job provides global exposure, structured processes, and collaboration with cross-functional teams.
Role Overview
The Safety Science Specialist supports Clinical Safety and PSS operations, covering the entire adverse event lifecycle, including:
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- Processing AE/SAE cases from clinical trials & post-marketing.
- Expedited reporting to clients and regulatory authorities.
- Narrative writing and MedDRA coding.
- Ensuring global compliance with safety guidelines and timelines.
Key Responsibilities
Adverse Event Case Processing
- Receive and process spontaneous & solicited AE/SAE reports.
- Perform safety data entry, QC checks, and database updates.
- Review cases for completeness, accuracy, and medical relevance.
- Write high-quality patient narratives for regulatory submissions.
- Conduct MedDRA coding and listedness assessment.
Safety Reporting & Compliance
- Ensure timely expedited reporting to global regulatory authorities.
- Submit SAE reports to investigators, ECs, clients, and partners.
- Support preparation of Periodic Safety Reports (PSRs) and Expedited Safety Reports (ESRs).
- Maintain AE tracking systems & project documentation.
Cross-Functional Collaboration
- Work with Medical Monitors, Data Management, QA, Regulatory, and DSMBs.
- Assist with database reconciliation.
- Prepare study safety files for archiving.
Quality & Audit Support
- Participate in audits and inspections.
- Support root-cause analysis and CAPA development.
- Perform peer quality checks of processed cases.
Required Qualifications
- 3–5 years of Pharmacovigilance experience (mandatory).
- Clinical trial case processing experience is essential.
- Education: PharmD (with 1-year residency/fellowship), B.Pharm, M.Pharm, Nursing, Life Sciences, Medical Sciences.
- Strong knowledge of SAE reporting, AE case handling, safety databases, and regulatory requirements.
- Excellent written communication and attention to detail.
- Ability to work independently with minimal supervision.
Preferred Skills
- Strong understanding of SOPs, WIs, and PV regulatory guidelines.
- Good presentation and training skills.
- Proficiency in MS Office and safety database systems.
Job Location
📍 Bangalore, India
🕒 Full-time
Why Join Fortrea?
- Work with global clinical safety teams.
- Exposure to end-to-end pharmacovigilance operations.
- Opportunity to contribute to global patient safety.
- Professional growth in a fast-evolving industry.
How to Apply
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