Job
Description
Safety Scientist ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Safety Scientist to join our diverse and dynamic team. As a Safety Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What you will be doing Conducting safety surveillance activities for assigned projects, including the review and interpretation of safety data. Partnership with cross-functional teams to ensure the safety of study participants and compliance with regulatory requirements. Contributing to the development and implementation of safety management plans and risk minimization strategies. Participating in safety review meetings and providing expert input on safety-related matters. Contributing to the preparation of safety-related documents for regulatory submissions and responses to regulatory queries. Oversees operational activities as the functional PV team lead. Assist project teams in client meetings when pharmacovigilance, safety surveillance, risk management which require expert knowledge beyond the expertise of Drug Safety Associates are discussed Support literature search and review projects by: Authoring literature search and review plans for routine pharmacovigilance, local literature, aggregate safety analysis, EMA Medical Literature Monitoring Defining search parameters (string terms) Conducting literature search and review as per project-specific plan Under the Guidance of a Director, Pharmacovigilance specialized services and/or Senior Principal/ Principal safety scientist, the safety scientist is responsible for: Aggregate safety report generation Coordinate aggregate safety report generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Generate and maintain aggregate safety report plans including generation of data specifications and literature search requirements. Author where necessary or review aggregate safety report drafts, including Sponsor authored drafts where ICON is legal representative Safety surveillance activities Coordinate and document the signal detection strategy Draft required plans and forms Manage and organize the source data Participate in development and generation of the data assessment visuals and tables in ICON visualization tool. Review interval and cumulative data as per safety surveillance plan Document and track all signal management activities Generate and / or Review signal detection reports, signal validation reports and signal assessment reports Organizes and coordinates internal and external meetings regarding signal management, including drafting of minutes Draft safety section of product reference documents (e.g. IB/ reference safety information, CCDS/CCSI, local labeling). Review of safety sections of a protocol, Review safety listings, review of ICSRs Generation of development risk management plans (dRMP), risk management plans (RMP), and risk evaluation and mitigation strategies (REMS) Coordinate risk management document generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Track initial RMP filing and subsequent updates Support risk management SMEs on appropriate strategy and design of risk management activities and risk minimization measures. Perform implementation, tracking and communication of risk management commitments including risk minimization measures Contribute to generation and maintenance of: Pharmacovigilance system master files (PSMF) and associated project plans. Pharmacovigilance agreements and associated project plans Other activities: - Assist with the maintenance of key performance indicators (KPIs) and compliance metrics. - Assist in preparation of audits and inspections. - Participate in ICON initiatives for the implementation and integration of new or enhanced: - Process development or maintenance (SOPs, WPs, templates, best practices) - Systems, databases and tools - Development and/or delivery of training courses on pharmacovigilance related topics to ICON Your profile Bachelors degree in life sciences, pharmacy, or related field; advanced degree preferred. Solid experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry. Strong understanding of pharmacovigilance principles, regulations, and guidelines. Excellent analytical and critical thinking skills, with the ability to interpret complex medical data. Effective communication skills, with the ability to cooperate effectively with cross-functional teams. Detail-oriented and able to work effectively in a fast-paced environment with changing priorities.
