Medical Review (ICSR / Aggregate reports)

Qualification: Drug Safety Physician MBBS , MD in Pharmacology or BDS

Experience : 0-5 Years

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.
- Valuable presentation skills.
- Analytical and problem-solving skills.
- Excellent verbal/written communication skills.
- Client-focused approach to work.
- Excellent organizational and prioritization skill

📌 Drug Safety Physician (Hyderabad)
🏢 Vizen Life Sciences
📍 Hyderabad