Key Responsibilities:
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.
Preferred Qualifications:
Experience:
1-3 years of relevant experience in Pharmacovigilance (PV) Book-In.
Education:
B.Pharm, M.Pharm, or Pharm.D.
Key Skills and Knowledge:
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 Details:
Work Mode:
100% Work From Office.
Work Schedule:
Alternate Saturdays are working days
