About Sigma-Chi Consulting
With more than a decade of experience, Sigma-Chi Consulting is a trusted biometrics partner to pharmaceutical and biotech sponsors, with teams in Hyderabad and Visakhapatnam supporting clients in the USA and Europe. We deliver biostatistics, statistical programming, clinical data management and AI-driven TLF quality control, with a strong focus on quality and on-time delivery.
Job Overview
As a Drug Safety Associate you will process and review adverse event cases and support safety data reconciliation for clinical and post-marketing programs.
Key Responsibilities
- Process individual case safety reports (ICSRs) for clinical trials and post-marketing sources
- Code adverse events and medications using MedDRA and WHODrug
- Write case narratives and perform quality review
- Support SAE reconciliation between safety and clinical databases
- Assist with periodic safety reports and signal detection activities
Requirements
- Degree in Pharmacy (B.Pharm, M.Pharm, Pharm.D), Life Sciences or Nursing
- 1–3 years of pharmacovigilance experience
- Working knowledge of MedDRA and WHODrug coding
- Understanding of ICH E2B and global safety reporting requirements
- Strong medical writing and communication skills
Good to have
- Experience with Argus or ArisG safety databases
What we offer
- Work on global pharma and biotech studies across therapeutic areas
- Mentoring from senior programmers and statisticians
- Exposure to our in-house AI tools for clinical reporting
- A collaborative team with clear career growth paths
How to apply
Use the Quick Apply button on this page, or send your CV to hr@sigma-chiconsulting.com with the job title in the subject line.
Job Features
| Job Category | Drug Safety |