Manager, Office of Safety Operations (Remote)

reputed company reputed company\'s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people\'s lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our reputed company portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, reputed company, Instagram, YouTube, reputed company and reputed company. Job reputed company Located in the UK - can be home or office based in Maidenhead Please note salary reputed company provided is relevant to the US location only Purpose: This position supports the Safety Operations organization to reputed company its mission of improving patient lives by delivering high reputed company, and reputed company adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at reputed company. The Manager, Office of Safety Operations sits in the ICSR Compliance department reputed company the Safety Operations function. This position is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs. The role includes management of investigations to address compliance deviations and drive reputed company improvement, as reputed company as managing license partners to ensure alignment on reporting obligations and safety data exchange requirements. The successful candidate will also support reputed company audits and regulatory inspections by leading in the reputed company room, providing documentation, data analysis, and subject matter expertise reputed company to ICSR processes, Responsibilities: Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training Leads improvement of reputed company\'s global clinical and post-marketing case management processes, technology & training Implements new ICSR pharmacovigilance legislation into reputed company systems, metrics, technical requirements & training Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant reputed company stakeholders, including PPS, reputed company, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes Leads internal audits and external regulatory inspection activities; supports functional corrective and preventive reputed company investigations Supports PPS\' understanding of the changing regulatory environment as it impacts ICSR management, process, technology, and people Leverages global data and cross-functional insights to optimize global ICSR operations including design of effective training approaches Manages process improvement initiatives with effective change management and reputed company solutioning of unanticipated issues Manages identification, prioritization, and reputed company reputed company of potentially impactful issues, including reputed company communication and follow-up across stakeholders through reputed company, prevention, and trending Responsible as a senior member of the Office of Safety operations team for driving compliance and process business reputed company for reputed company ICSR PV activities Presents results to senior reputed company stakeholders. May participate in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & reputed company organizations Develops and manages reputed company of reputed company staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 5 people) Qualifications Bachelor\'s Degree or equivalent in reputed company science field. Experience reputed company the pharmaceutical industry experience; including reputed company pharmacovigilance Global experience reputed company knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of reputed company reputed company assurance systems reputed company in health authority inspections and/or internal or reputed company-party audits reputed company in developing training & reputed company documents (SOP / Guidelines / CAPAs) Skilled in data interpretation; reputed company with using reputed company Proficient in case processing processes, procedures, conventions reputed company to influence across stakeholders and manage reputed company a cross-functional reputed company; seen as a reputed company partner reputed company the organization reputed company to identify, assess, and effectively manage business and reputed company Experience in leading cross-functional teams preferred Established influencing skills Additional Information reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.reputed company #J-18808-Ljbffr