About the role
- Duplicate Search:
- Conduct thorough duplicate searches to ensure accuracy and avoid case duplication.
- Case Validity Assessment:
- Evaluate cases to confirm validity in line with defined criteria, including completeness and relevance of data.
- Coding of Suspect Product:
- Accurately code suspect products using industry-standard dictionaries (e.g., CCD-ODD).
- Event Coding and Seriousness Assessment:
- Perform MedDRA coding for adverse events.
- Assess and document the seriousness of cases as per regulatory guidelines.
- Case Book-In Process:
- Process spontaneous, E2B, and literature cases, ensuring all essential data fields are completed.
- Ensure adherence to company procedures and timelines for case book-in.
- Experience: 1-3 years of relevant experience in Pharmacovigilance (PV) Book-In.
- Education: B.Pharm, M.Pharm, or Pharm.D.
- Strong understanding of PV regulations and guidelines.
- Proficiency in ICSR book-in requirements and formats.
- Familiarity with ICSR tools and systems.
- Expertise in quality assurance and compliance.
- Attention to detail, accuracy, and speed in case processing.
- Excellent communication and coordination skills.
- Strong problem-solving and decision-making ability
- Work Mode: 100% Work From Office.
- Work Schedule: Alternate Saturdays are working days