As a PSUR Specialist, your primary responsibility will be to author and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities. You will play a crucial role in ensuring the accuracy, completeness, and regulatory compliance of all PSURs. Additionally, you will be tasked with performing literature searches to gather relevant data for PSUR preparation and validating the information obtained to ensure accuracy. Your role will involve extracting and validating data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). You will also be responsible for generating Line Listings (LL) from the safety database for inclusion in PSURs. Effective process management is key, as you will need to manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Providing reliable support for high-priority ad-hoc activities related to PSUR preparation will also be part of your daily tasks. Client interaction is an important aspect of this role, as you will communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies. It will be your responsibility to ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines. Furthermore, you will serve as a subject matter expert (SME) for PSUR preparation and review, providing training and mentoring to team members on PSUR-related processes and regulatory requirements. To excel in this role, you should hold a Bachelor's degree in a relevant scientific or medical field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review, is essential. Knowledge of regulatory requirements for PSURs/PBRERs, strong analytical and problem-solving skills, excellent written and verbal communication skills, proficiency in safety databases and data extraction/validation processes, as well as strong organizational skills are key qualifications needed for this position. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert support will be critical for success in this role.,
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.,