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1.0 - 5.0 years
0 - 0 Lacs
bangalore, chennai, united arab emirates
On-site
Roles and Responsibilities; Perform medical review of ICSRs for seriousness, causality, and expectedness. Assess adverse events (AEs/SAEs) in clinical trial and post-marketing settings. Write and validate concise and medically accurate narratives . Conduct literature review and assist in signal detection & risk analysis . Support preparation of aggregate reports (PSUR, DSUR, PBRER). Collaborate with PV scientists, data entry teams, and global medical reviewers. Qualifications: MBBS / BDS / BAMS / BHMS / Pharm.D / M.Pharm (Pharmacology) 1-5 years of experience in Pharmacovigilance, preferably in medical review/assessment roles Interested to apply can share you CV in Whatsapp/Call to 934273575...
Posted 3 months ago
1.0 - 4.0 years
0 - 0 Lacs
bangalore, chennai, noida
On-site
The Clinical Safety Reviewer (CSR) is responsible for evaluating and interpreting adverse events (AEs), serious adverse events (SAEs), and product safety data collected during clinical trials or post-marketing surveillance. The role ensures scientific and regulatory accuracy in case assessments, contributing to patient safety and regulatory compliance. Roles and Responsibilities; Review clinical safety data including ICSRs, SAEs, and narratives for accuracy and medical completeness. Assess seriousness, expectedness, and causality based on protocol, IB, and regulatory guidelines. Ensure the consistency of MedDRA coding and WHO Drug coding in line with global standards. Review and approve fina...
Posted 3 months ago
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