ICSR Group Head (General Manager)

The ICSR Group Head (General Manager) is responsible for overseeing the overall operations and quality of the ICSR teams. This includes literature screening and review, HA submission, data entry, case processing, and quality assurance. As the GM, you will lead the integrated ICSR management team, overseeing case intake, processing, and reporting functions. It is essential to ensure compliance with global regulations, internal procedures, quality standards, and timelines for ICSR activities. Your role involves managing, coaching, and developing a team of ICSR team leads, reviewers, specialists, and quality checkers. These professionals are responsible for performing end-to-end ICSR activities, from booking to submission. Coordination with other PV functions, cross-functional stakeholders, external vendors, and partners is crucial to ensure effective and efficient ICSR operations. This includes aligning processes, communicating requirements, and resolving issues. You will be responsible for monitoring and reporting ICSR operations metrics and performance indicators. This includes tracking the number of ICSRs received, processed, and submitted, as well as assessing quality, timeliness, compliance rates, and productivity. Identifying and implementing process improvements and best practices for ICSR operations is also a key aspect of the role. Supporting audits, inspections, and CAPAs related to ICSR operations is part of the responsibilities. This involves preparing for audit/inspection readiness, responding to findings, and implementing corrective and preventive actions. The ideal candidate should have 15-20 years of relevant experience in PV ICSR operations, a Master's degree in pharmacy, life sciences, or related fields, and possess excellent knowledge of PV regulations and guidelines, ICSR operations methodologies, reporting and documentation, tools and systems, quality assurance, compliance, team management, leadership, communication, coordination, problem-solving, and decision-making.,