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Pharmacovigilance (Pv) Book-In Specialist

1-3 years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance (PV) Book-In Specialist

Key Responsibilities:

  • Duplicate Search:
    Conduct thorough duplicate searches to ensure case accuracy and prevent duplication.

  • Case Validity Assessment:
    Evaluate cases for validity according to predefined criteria, ensuring completeness and relevance of data.

  • Coding of Suspect Product:
    Accurately code suspect products using industry-standard dictionaries such as CCD-ODD.

  • Event Coding and Seriousness Assessment:
    Perform MedDRA coding for adverse events and assess case seriousness in compliance with regulatory guidelines.

  • Case Book-In Process:
    Process spontaneous, E2B, and literature cases, ensuring all required data fields are accurately filled and timelines are met. Ensure adherence to company procedures for case book-in.

Preferred Qualifications:

  • Experience: 1-3 years in Pharmacovigilance (PV) Book-In.
  • Education: B.Pharm, M.Pharm, or Pharm.D.

Key Skills and Knowledge:

  • In-depth understanding of pharmacovigilance regulations and guidelines.
  • Proficiency in ICSR book-in requirements and formats.
  • Familiarity with ICSR tools and systems.
  • Expertise in quality assurance and compliance.
  • Strong attention to detail, accuracy, and speed in case processing.
  • Excellent communication and coordination skills.
  • Strong problem-solving and decision-making abilities.

Work Details:

  • Work Mode: 100% in-office.
  • Work Schedule: Alternate Saturdays are working days.