Job Description 1: ICSR-Data Entry Associate
Qualifications:
- M-Pharma, PharmD, or B-Pharm
Experience:
- 1 to 3 years
Key Responsibilities:
- 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:
- 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
