Drug Safety Physician

Role & Responsibilities

• Perform medical review and analysis of adverse event and adverse reaction reports

• Conduct signal detection, evaluation and ongoing safety surveillance

• Provide medical guidance to Drug Safety Associates and Specialists

• Review narratives for Clinical Study Reports and regulatory documents

• Prepare and review Benefit Risk Assessments, Safety Evaluation Reports, Clinical Overviews and Expert Statements

• Act as pharmacovigilance representative and safety scientist

• Maintain thorough knowledge of assigned product safety profiles

• Ensure compliance with global regulatory reporting timelines

• Communicate review issues with Project Managers and stakeholders

• Perform case medical review, causality assessment, seriousness and expectedness evaluation

• Conduct medical literature review for safety assessments

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Qualification

• Graduation / Post Graduation in Medicine (MBBS / MD)

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Experience

• Freshers or candidates with Pharmacovigilance / Drug Safety experience preferred

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Skills

• Strong knowledge of GCP, GVP and international PV regulations

• Excellent written and verbal communication skills

• Clinical data interpretation and medical judgment

• Case processing guidance and regulatory compliance

• Literature review and safety signal analysis

• Team collaboration and multitasking abilities

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About the Company

• A global pharmacovigilance and regulatory services organisation supporting multinational pharmaceutical clients in ensuring patient safety, compliance and lifecycle drug risk management

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