Manager, PV (Pharmacovigilance) Operations
Site Name: USA - North Carolina - Research Triangle Park, Belgium-Wavre, UK - Middlesex - Stockley Park Posted Date: Sep 21 2021 The Manager, PV (Pharmacovigilance) Operations role will support Pharmacovigilance Services responsible for start-up of clinical trials and implementation, oversight and management of vendors operating Global Pharmacovigilance HUBs, managing adverse event collection and reporting. This role will work directly with key stakeholders such as Clinical Study Teams, SERM, MAPS Quality Team, and global service provider(s). The position holder is responsible for proactive engagement with stakeholders to drive quality improvement and process simplification, aligning supplier delivery with GSK strategy, adhering to the GSK third party engagement framework, implementing third party oversight, supporting Regulatory inspections, investigating/resolving issues and escalations from stakeholders and advancing methodology/process improvement initiatives. The position holder works across a matrix environment, across GSK business units, across Local Operating Companies and outsourced provider(s). Key Responsibilities: Work with PV Operations Directors to drive continuous improvement and establish, build, and nurture relationships with vendors, internal stakeholders such as Clinical Teams, SERM, MAPS, IT and Quality Groups to achieve synergistic collaborative effects and process improvements. Develop and manage global monitor programs for sponsor oversight of Vendor quality and performance of License Partner, PMS, Spontaneous and Periodic intake and data entry process vendor adherence to training requirements, reconciliations. Develop and provide training to the vendor(s) and stakeholders using innovative and effective approaches (could include system or process training). Partner in evaluating innovative technology solutions to drive improvement in quality and reduce overall risk. Develop and implement effective Corrective and Preventative Actions (CAPA) when necessary. Develop innovative strategies for to drive process improvement and simplify the global model. Conduct routine in stream and ad hoc monitoring and trend results. Support inspections and audits as needed. Resolve issues/escalations reported by local operating companies. Provide input, guidance for adverse event case management processes to influence key company strategies such as drive to zero touch processing. May Manage a team of scientific staff responsible for supporting Adverse Event Management activities to ensure appropriate prioritisation, resourcing to support the business strategy and reduce risk. Builds external relationships with key stakeholders and senior leaders Resolves issues and concerns escalating , where resolution is not possible or there is impact across CMG Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in life sciences or medically-related field or previous experience equating to educational requirements 5 + years' experience including experience working in Quality, Vendor Management, or Safety Experience and knowledge of global Pharmacovigilance Regulatory Requirements Experience and knowledge of Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements Experience with and understanding of medical and drug terminology Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge of the GSK business structure (Pharma, Vaccines) Proven experience of Prioritisation and time management Strong communication skills Logical thinking to map complex operational needs into robust, clear processes and system requirements Experience in working with global service providers/vendor management Cultural awareness and excellent global communication skills Experience with Argus or Safety Databases Ability to influence, persuade and make sound risk-based decisions Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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