Clinical Safety Reviewer

The Clinical Safety Reviewer (CSR) is responsible forevaluating and interpreting adverse events (AEs), serious adverse events (SAEs), and product safety datacollected during clinical trials or post-marketing surveillance. The role ensuresscientific and regulatory accuracyin 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.

• Argus

Interested to apply can share you CV in Whatsapp/Call to 9342735755