Clinical Safety Reviewer

Job Description

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.
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Keyskills :
meddra codingclinicalsafetyreviewersafetyreviewindiamedicalreviewersignaldetectiondrugsafetyphysician