ICSR Group Head ( General Manager)

Job Summary

The ICSR Group Head ( General Manager) is responsible for overseeing the overall operations and quality of the ICSR teams, including literature screening and review, HA submission, data entry, case processing and quality assurance.

Job Responsibilities

• Lead the integrated ICSR management team, overseeing case intake, processing, and reporting functions.
• Ensure compliance with global regulations, internal procedures, quality standards, and timelines for ICSR activities.
• Manage, coach, and develop a team of ICSR team leads, reviewers, specialists, and quality checkers, who are responsible for performing the end-to-end ICSR activities, from booking to submission.
• Coordinate with other PV functions, cross-functional stakeholders, external vendors, and partners to ensure effective and efficient ICSR operations, such as aligning the ICSR processes, communicating the ICSR requirements, resolving the ICSR issues, etc.
• Monitor and report the ICSR operations metrics and performance indicators, such as the number of ICSRs received, processed, and submitted, the quality and timeliness of the ICSRs, the compliance rate, the productivity, etc.
• Identify and implement process improvements and best practices for ICSR operations, such as optimizing the ICSR workflows, standardizing the ICSR procedures, enhancing the quality checks, etc.
• Provide support for audits, inspections, and CAPAs related to ICSR operations, such as preparing the audit/inspection readiness, responding to the findings, implementing the corrective and preventive actions, etc.
  
  

Job Requirements

• Experience: 15 - 20 years of relevant experience in PV ICSR operations.
• Education: Master's degree in pharmacy, life sciences, or related fields.
• Skills and Competencies: Excellent knowledge of PV regulations and guidelines, ICSR operations methodologies, ICSR reporting and documentation, ICSR tools and systems, quality assurance and compliance, team management and leadership, communication and coordination, problem-solving and decision-making.