Principal Drug Safety Physician

Role & Responsibilities

Conduct detailed medical review and assessment of Individual Case Safety Reports (ICSRs) in safety databases
Ensure accurate selection and coding of adverse events as per MedDRA guidelines
Assess seriousness, expectedness, listedness and causality of reported cases
Review suspect and concomitant medications, laboratory data, medical history and case narratives
Prepare and provide Company Clinical Comments and medical narratives
Ensure compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP) and ICH guidelines
Implement EMA and global regulatory requirements in safety reporting processes
Maintain high quality and accuracy in safety case assessments
Support audits, inspections and continuous quality improvement initiatives

Qualification

MBBS / MD or equivalent medical degree

Experience

Minimum 5–8 years of experience in Pharmacovigilance / Drug Safety / Medical Review roles

Skills

ICSR medical review and causality assessment
MedDRA coding and narrative writing
Strong knowledge of GVP, GCP, ICH and EMA guidelines
Safety database handling (ARGUS, ARISg, etc.)
Analytical skills and medical judgement
Excellent documentation and communication skills

About the Company

The organization is a global pharmacovigilance and clinical research service provider delivering comprehensive drug safety, regulatory and clinical operations solutions to pharmaceutical and biotechnology companies worldwide, with a strong commitment to patient safety and regulatory compliance.