Job Openings in Pharmacovigilance Department at Arcolab
About Company
Arcolab is a life science-focused Global Capability Centre designed to provide diverse capabilities across functions. With a strong focus on customer centricity and delivering excellence, Arcolab offers state-of-the-art business services and solutions for driving transformation while maintaining 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 high standards in its operations.
Position Names:
- ICSR-Data Entry Associate
- ICSR-QC/PR Reviewer
Organization:
Arcolab
Qualification:
- M-Pharma
- PharmD
- B-Pharm
Experience:
- 1 Year – 5 Years
Salary:
₹25,000 – ₹35,000 /month
Location:
Bangalore
Job Descriptions:
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: Extract relevant information from literature, regulatory, and spontaneous reports for data entry.
- Ensure Completeness and Correctness: Include demographic information, adverse event details, medical history, concomitant medications, reporter information, seriousness determination, expectedness, and causality assessment.
- Data Reconciliation: Ensure consistency and accuracy in reported information.
- Stay Updated: Keep abreast of changes in pharmacovigilance regulations, guidelines, and industry best practices to ensure adherence to evolving requirements.
2. ICSR-QC/PR Reviewer
Qualifications:
- M-Pharma, PharmD, or B-Pharm
Experience:
- 3 to 5 years
Job Summary:
The ICSR Quality Reviewer ensures the accuracy, completeness, and compliance of ICSRs within the Pharmacovigilance department. This role involves meticulous review and quality assessment of ICSRs, ensuring adherence to regulatory requirements and company standards.
Key Responsibilities:
- Review and Assessment: Assess ICSRs (literature, regulatory, and spontaneous cases) for accuracy, completeness, and compliance with regulatory requirements and internal SOPs.
- Quality Control Checks: Perform checks on ICSR data entries, including adverse event coding, seriousness assessment, and causality determination to ensure consistency and accuracy.
- Verify Consistency: Ensure consistency between source documents and data entered into the safety database, resolving any data quality issues.
- Guidance and Training: Provide guidance and training to PV team members on ICSR documentation requirements, quality standards, and best practices.
- Stay Updated: Keep updated on changes in pharmacovigilance regulations, guidelines, and industry best practices to ensure adherence to evolving requirements.
Interested candidates can share their CVs to: Dev.kiran@arcolab.com
Meta Description:
Join Arcolab’s Pharmacovigilance Department in Bangalore. Openings for ICSR-Data Entry Associate and ICSR-QC/PR Reviewer. Apply now!