Qualification: Drug Safety Physician –MBBS , MD in Pharmacology
Job Description:
• Provide medical review, analysis, and guidance during the case handling and reporting cycle of
Individual Case Safety Reports
and ADR reports for investigational and marketed products.
• Conduct detailed
ICSR Medical Review
to assess causality, seriousness, and completeness, ensuring compliance with regulatory requirements.
• Writing of safety sections, including benefit-risk assessment of Aggregate Reports such as PSURs, CASRs, and PADERs.
• Provide guidance to Drug Safety Associates on the medical aspects of drug safety, including case-by-case assessments and aggregate analysis.
• Analyze ADRs during ongoing surveillance and signal detection, including independent analysis of safety risks.
• Participate in Safety Review Meetings and client discussions to provide medical insights and recommendations.
• Accountable for maintaining personal readiness in response to internal audits or regulatory inspections.
Skills:
• Clinical research or Pharmacovigilance knowledge.
• Strong understanding of
ICSR processes
and global safety regulations.
• Good presentation skills.
• Analytical and problem-solving skills.
• Excellent verbal/written communication skills.
• Client-focused approach to work.
• Excellent organizational and prioritization skills.
