Drug Safety Physician

Role & Responsibilities

• Review and assess individual case safety reports from clinical trials, spontaneous and solicited sources

• Determine regulatory reportability and perform case triage

• Assess seriousness, causality and relatedness of adverse events

• Review narratives, MedDRA coding, labeling and adverse event selection

• Escalate complex safety cases to client medical review teams

• Assess litigation and special case scenarios

• Coordinate with client therapeutic teams for case resolution

• Maintain up-to-date product safety profile knowledge

• Ensure compliance with global health authority regulations

• Perform additional drug safety activities as assigned

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Qualification

• MBBS / MD

• MCI / State Medical Council Registration Mandatory

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Experience

• 1 – 3 years in Pharmacovigilance as Medical Reviewer

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Skills

• Safety database handling and MedDRA coding

• Case triage and regulatory compliance

• Customer and stakeholder communication

• Presentation and people management skills

• Strong organizational, leadership and time management abilities

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About the Company

• A leading pharmacovigilance and drug safety services organization supporting global pharmaceutical clients in ensuring patient safety and regulatory compliance

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