Data Entry Specialist – ICSR (Pharmacovigilance)
Company: Vizen Life Sciences Pvt Ltd
Location: [City, Country]
Employment Type: Full-Time
Position Overview
Vizen Life Sciences is seeking a dedicated Data Entry Specialist – ICSR with 2–5 years of experience in pharmacovigilance. The ideal candidate will be responsible for accurate and timely case data entry, literature review, and support for adverse event case processing within the safety database. This role is critical to maintaining data integrity, regulatory compliance, and pharmacovigilance quality standards.
Key Responsibilities
Triage incoming reports to assess completeness, legibility, and validity.
Book-in and perform data entry of individual case safety reports (ICSRs) into the safety database.
Request follow-ups and manage queries to ensure case completeness.
Code safety data accurately using industry-standard coding systems.
Write case narratives based on reported adverse events.
Perform literature searches to support case processing and signal detection.
Participate in client meetings and provide updates as required.
Support audit and inspection preparations, including participation and follow-up.
Required Qualifications & Experience
Educational Background: B.Pharm, M.Pharm, or Pharm.D.
Experience: 1–3 years in pharmacovigilance or drug safety, with exposure to ICSR case handling and database entry.
Key Skills & Competencies
Strong analytical and problem-solving skills.
Proficient in database management and literature searches.
Excellent verbal and written communication skills.
Client-focused and able to work in a collaborative, regulatory-driven environment.
Attention to detail and ability to maintain accuracy under tight timelines.
Why Join Vizen Life Sciences?
Work in a compliant, high-quality PV environment supporting global pharmacovigilance operations.
Gain exposure to ICSR data handling, case narrative writing, and regulatory reporting processes.
Opportunity to develop skills in safety databases, literature review, and PV audit readiness.
SEO & GPT Optimized Keywords: Pharmacovigilance jobs, ICSR data entry, drug safety specialist, case narrative writing, PV database management, literature search, regulatory compliance, Vizen Life Sciences careers.
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