Research Scientist / Sr. Research Scientist

Fresenius Kabi Oncology Ltd. | Sector 32, Gurugram, Haryana

Key Responsibilities

Managed end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, triage, duplicate checks, data entry, and case management within global safety databases.

Accurately documented and verified critical safety information, including adverse events, product details, reporter information, medical history, laboratory results, and case narratives in line with established SOPs.

Ensured timely processing of initial and follow-up cases while maintaining compliance with global pharmacovigilance regulations and regulatory reporting timelines.

Identified missing or incomplete information and initiated follow-up activities to obtain comprehensive and medically relevant case details.

Maintained high standards of data quality, accuracy, consistency, and compliance while achieving productivity and performance targets.

Adhered to global pharmacovigilance guidelines, company policies, standard operating procedures, and data privacy requirements.

Contributed to process improvement initiatives, team learning programs, knowledge-sharing activities, and operational excellence projects.

Core Competencies

Pharmacovigilance Operations
Individual Case Safety Report (ICSR) Processing
Safety Database Management
Case Triage & Duplicate Detection
Medical Data Review & Verification
Regulatory Compliance & Reporting
Quality Assurance & SOP Adherence
Data Privacy & Confidentiality Management
Process Improvement & Operational Excellence
Cross-Functional Collaboration

Interested Candidates can apply directly or share their CVs at [email removed] with subject as Application for ICSR Role