
Tata Consultancy Services (TCS), a global leader in IT services and consulting, is expanding its Life Sciences division. The company is currently seeking experienced professionals for the role of Clinical Safety Scientist. This position is ideal for candidates with a strong background in Pharmacovigilance and Aggregate Reporting who wish to work with a world-class consulting organization.
This role focuses on the scientific evaluation of drug safety data and the authoring of critical regulatory documents to ensure patient safety and global compliance.
Job Responsibilities & Expertise Required
The role is divided into two core domains: Scientific Literature Analysis and Regulatory Aggregate Reporting.
1. Literature Review & Analysis
- Conducting systematic literature reviews to identify ICSRs (Individual Case Safety Reports) and new safety signals.
- Assessing scientific articles for inclusion in Drug Safety Reports (DSR) and Aggregate reports.
- Designing and interpreting medical studies, focusing on study power and levels of evidence for safety analysis.
- Tailoring literature search strategies using medical indexing thesauri (e.g., Embase/Medline).
2. Aggregate Report Authoring
- Authoring safety sections for global regulatory documents including PBRER (Periodic Benefit-Risk Evaluation Report), DSUR (Development Safety Update Report), and SSSRs.
- Drafting and updating Risk Management Plans (RMP) and implementation strategies.
- Collaborating with clinical safety teams to provide methodology for data presentation (e.g., use in special populations, medication errors, and characterization of risks).
Candidate Profile
| Criteria | Details |
| Position | Clinical Safety Scientist |
| Experience | 5 to 9 Years (Relevant experience in PV/Clinical Safety is mandatory) |
| Education | B.Pharm, M.Pharm, B.Sc, or M.Sc (Life Sciences/Pharma) |
| Work Location | Noida, Uttar Pradesh |
| Industry | Pharma / Healthcare / Clinical Research |
Application Details
- Last Date to Apply: January 10, 2026
- How to Apply: Eligible candidates can apply through the TCS iBegin portal or official career channels.
TCS is looking for individuals who can interpret current expert therapeutic guidelines and apply them to complex safety analyses, ensuring that all outputs are scientifically accurate and meet stringent regulatory standards.
