Role & Responsibilities
Perform medical assessment of Individual Case Safety Reports (ICSRs) in the safety database
Conduct medical evaluation of serious and non-serious adverse event cases
Assess quality of vendor medical assessments against defined KPIs
Issue follow-up medical queries and ensure completeness of case information
Maintain medical knowledge of product safety profiles across therapeutic areas
Monitor case workflows to ensure timely processing and compliance
Collaborate with Medical Safety and Pharmacovigilance teams
Support audits, regulatory inspections, and internal trainings
Contribute to pharmacovigilance activities for clinical and post-marketing products
Qualification
MBBS or MD
Experience
Minimum 3 years in pharmaceutical or biotech industry
At least 2 years in pharmacovigilance / patient safety
Minimum 2 years of hospital or private clinical practice
Skills
ICSR medical review
Pharmacovigilance compliance
Medical query management
Clinical judgment and safety evaluation
Strong communication and teamwork skills
Ability to work in a global, fast-paced environment
About the Company
The organization is a global science and technology leader delivering innovative solutions in healthcare, life sciences, and electronics, with a strong commitment to improving and prolonging patient lives across oncology, neurology, and fertility therapeutic areas.