PV Operations - ICSR Management Apprenticeship

Job description

Key Responsibilities Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product. Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs) Escalate identified problems or issues to the appropriate Management Personnel with PV Operations Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes. Ensures third parties/vendors develop and implement robust processes to support quality-driven organization. Demonstrate GSK values Additional Responsibilities Work with relevant teams to ensure accuracy and functionality of – and appropriate access to – websites, collaborative areas/databases and documents that are a key resource for the Global Safety organisation Provide support for the following: compile agendas, coordinate key meetings, capture and file meeting minutes, document retention and help create meeting materials Ensure the smooth running of meetings, liaise with technical teams as appropriate Support effective communication within and outside the department by reformatting information provided by subject matter experts Assist with audit & inspection activities, coordinate the collation of audit request documents - upload and reconcile documents provided against the requests Maintain an awareness and be an early adopter of new technology to select the most appropriate application for a given purpose Manage and triage group mailboxes as necessary Provide technical support for department processes and maintain documentation/repositories as needed Provide administrative support on new hire onboarding Assist with process improvement activities May be Subject Matter Expert/Champion or system business owner in specific areas or systems Skills Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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