Pharmacovigilance (PV) Case Book-In Specialist
Location: [City, Country] – 100% On-Site
Department: Pharmacovigilance (PV)
Work Schedule: Full-time, alternate Saturdays working
Company Overview
Join a leading pharmaceutical organization committed to patient safety and regulatory compliance. We focus on innovative drug development and robust pharmacovigilance practices, ensuring the highest quality of adverse event monitoring and reporting globally.
Position Summary
We are seeking a Pharmacovigilance Case Book-In Specialist with 1–3 years of experience in PV book-in processes. The ideal candidate will manage duplicate searches, case validity assessments, coding of suspect products, and event coding, ensuring compliance with global pharmacovigilance regulations and company SOPs.
This is a 100% on-site role with responsibilities in processing spontaneous, E2B, and literature cases, maintaining data integrity, and supporting PV operations.
Key Responsibilities
Duplicate Search & Case Assessment
Conduct thorough duplicate case searches to prevent redundant case entries.
Evaluate case validity to ensure completeness, relevance, and compliance with defined criteria.
Product & Event Coding
Accurately code suspect products using standard dictionaries (e.g., CCD-ODD).
Perform MedDRA coding for adverse events.
Assess and document case seriousness according to regulatory guidelines.
Case Book-In Process
Process spontaneous, E2B, and literature cases with full compliance to timelines and company procedures.
Ensure all essential data fields are accurately completed for every case.
Maintain high data quality and adherence to PV SOPs.
Preferred Qualifications
Experience: 1–3 years in Pharmacovigilance (PV) Case Book-In.
Education: B.Pharm, M.Pharm, or Pharm.D.
Key Skills & Competencies
Strong knowledge of global PV regulations and ICSR requirements.
Proficiency in ICSR book-in tools, formats, and systems.
Expertise in quality assurance, compliance, and case accuracy.
Attention to detail, high accuracy, and efficiency in case processing.
Excellent communication, coordination, and problem-solving skills.
Ability to make data-driven decisions and ensure compliance with SOPs.
Work Details
Work Mode: 100% On-Site
Schedule: Alternate Saturdays as working days
Why Join Us?
Opportunity to work in a globally recognized pharmacovigilance team.
Exposure to ICSR management, regulatory compliance, and quality processes.
Develop expertise in adverse event reporting and global PV operations.
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