Principal Scientist, PV Operations

Principal Scientist, PV Operations / Manager, PV Operations The key purpose of this role is to support Pharmacovigilance Operations "PV Ops" ICSR Management. Depending on candidates' level of experience, this position may be considered at either the Principal Scientist or Manager level. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in‑office work. In this role you will Support Scientists with enhancement of knowledge and skills for ICSR Management activities Lead and oversee Clinical Trial and/or post‑Market study (PMS) related activities such as protocol review, Safety Management Plan review, study/program set‑up, reconciliation, end‑of‑study unblinding, etc.; support case management activities for spontaneous event reports Act as a global PV Operations Leader for process discussions, including queries on strategy/policy related decisions; author or provide significant input into the development of written standards Generate new ideas and proposals for global implementation; contribute to advancement of ICSR management, program, clinical trial set‑up and maintenance methodology and processes Prioritise work and time management in line with business needs Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (e.g., 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 Ensure third parties/vendors develop and implement robust processes to support quality‑driven organization At the "Manager" Level: People lead, providing development opportunities and capability building, provide guidance and direction to the team to achieve objectives; and/or Act as a PV Ops leader for process discussions and changes, reinforcing the principle of SPADM (single point accountability decision making) Basic Qualifications & Skills Degree in life sciences or medically related field or previous experience equating to educational requirements End‑to‑end case processing knowledge, from intake to submissions In‑depth knowledge of pharmacovigilance (PV) concepts and project management within PV, including regulatory requirements, documentation, process design, implementation, and written standards Experience in clinical trials from a PV perspective (not just general clinical trial roles such as CRA), or post‑marketing PV; candidates with only one area may be considered for a suitable team fit Experience in PV project management/oversight task Preferred Qualifications & Skills Technological experience, such as working on automation or AI projects, rolling out new technology, or serving as an SME in such initiatives Ability and willingness to adapt to new technology and automation trends in PV Closing Date for Applications 23rd of December, 2025 (COB) GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr