Book in (ICSR)

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