About the role
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.