Medical Assessor Pharmacovigilance CLIN BIOSCIENCES

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 9342735755

Posted 3 days ago

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Clinical Safety Reviewer CLIN BIOSCIENCES

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 final case versions for submission to regulatory authorities. Collaborate with medical writers, PV associates, and biostatisticians on aggregate report contributions. Participate in signal detection and risk assessment meetings (as required). Ensure compliance with global pharmacovigilance regulations (e.g., ICH E2E, GVP). Eligibility / Qualifications: MBBS / BDS / BPharm / PharmD / MPharm / BHMS / BAMS with relevant PV training. Minimum1- 4 years experience in pharmacovigilance or clinical safety (mandatory for mid-level). Strong understanding of clinical trial protocols, GCP, MedDRA, and WHO-DD. Hands-on experience with PV databases like Argus , ARISg , or equivalent. Interested to apply can share you CV in Whatsapp/Call to 9342735755

Posted 3 days ago

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