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About Company

Arcolab is a life science-focused Global Capability Centre designed to provide diverse capabilities across functions, with SMEs prioritizing customer centricity and delivering excellence. Arcolab aims to provide state-of-the-art business services and solutions for driving transformation, with a strong focus on global quality and regulatory standards. Recognized among the top 3 outstanding global capability centers (GCCs) of the year 2023 in the EY GCC Awards, Arcolab is dedicated to maintaining high standards in its operations.

Position Name :

ICSR-Data Entry Associate \ ICSR-QC/PR Reviewer

Organization :

Arcolab

Qualification:

M-Pharma, PharmD, or B-Pharm

Experience:

1 Year - 5 Years

Salary:

25,000 - 35,000 /month

Location:

Bangalore

Job Description 1: ICSR-Data Entry Associate

Qualifications:

  • M-Pharma, PharmD, or B-Pharm

Experience:

  • 1 to 3 years

Key Responsibilities:

  1. Data Entry:
    • Accurately enter individual case safety reports (ICSRs) into the pharmacovigilance database following standard operating procedures (SOPs) and regulatory requirements.
    • Review source documents (e.g., literature, regulatory, and spontaneous reports) to extract relevant information for data entry.
    • Ensure completeness and correctness of data entry, including demographic information, adverse event details, medical history, concomitant medications, reporter information, seriousness determination, expectedness, and causality assessment.
    • Perform data reconciliation to ensure consistency and accuracy in reported information.
    • Stay updated on changes in pharmacovigilance regulations, guidelines, and industry best practices, and ensure adherence to evolving requirements.

Job Description 2: ICSR-QC/PR Reviewer

Qualifications:

  • M-Pharma, PharmD, or B-Pharm

Experience:

  • 3 to 5 years

Job Summary:

  • The ICSR Quality Reviewer plays a critical role in ensuring the accuracy, completeness, and compliance of ICSRs within the Pharmacovigilance department. This role involves meticulous review and quality assessment of ICSRs, adherence to regulatory requirements and company standards.

Key Responsibilities:

  1. Review and Assessment:
    • Review and assess ICSRs (Case types: literature, regulatory, and spontaneous cases) for accuracy, completeness, and compliance with regulatory requirements and internal standard operating procedures (SOPs).
    • Perform quality control checks on ICSR data entries, including adverse event coding, seriousness assessment, and causality determination, to ensure consistency and accuracy.
    • Verify the consistency between source documents and data entered into the safety database, identifying discrepancies and resolving data quality issues.
    • Provide guidance and training to PV team members on ICSR documentation requirements, quality standards, and best practices.
    • Stay updated on changes in pharmacovigilance regulations, guidelines, and industry best practices, and ensure adherence to evolving requirements.

Interested candidates can share their CVs to: Dev.kiran@arcolab.com