PV Ops, Vendor Quality Lead
Site Name: USA - North Carolina - Research Triangle Park, Belgium-Wavre, UK - Middlesex - Stockley Park Posted Date: Sep 27 2021 Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this PV Ops, Vendor Quality Lead role could be an ideal opportunity to explore. As a PV Ops, Vendor Quality Lead, you will be responsible for 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 GSK LOCs and advancing methodology/process improvement initiatives. The position holder works across a matrix environment, across GSK business units, across 65 LOCs and 150 markets and outsourced provider(s). The position holder will ensure that PV Operations activities provided by the suppliers align with GSK standards, that regulatory timelines are achieved, and that MI/PV standards are delivered per the outsourcing contract. The position holder will be critical to ensure the suppliers enabled to deliver the agreed upon service and meets key performance indicators. This position holder will play a key visible role to ensure that GSK regulatory and reputational risk is minimized. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Work with PV Ops Directors to facilitate Vendor weekly meetings, providing information to drive continuous improvement and establish, build, and nurture relationships with vendors, LOC and internal stakeholders. Develop training materials to drive vendor performance. Develop and manage regional monitor programs for Vendor quality performance of License Partner, PMS, Spontaneous and Periodic intake and book in, SDEA annual compliance reviews, Periodic submissions, literature searches and vendor adherence to training requirements, reconciliations. Conduct regional trending analysis and were necessary report deviations per GSK and Vendor processes ensuring appropriate CAPA are implemented and closed out in a timely manner. Develop and implement effective Corrective and Preventative Actions (CAPA) for a regional HUB. Point of Contact for ongoing queries or issues raised from vendors, Global Safety and local operating companies. Implement process improvement strategies for to drive improvement, standardize the operating model. Conduct routine in stream and ad hoc monitoring for workflow, reporting and quality demonstrating robust sponsor oversight of service providers. Trend results and report to Regional Directors Liaise with global service providers to ensure focused retraining on areas of improvement occurs. Resolve issues/escalations reported by local operating companies May participate on key organization project teams such as Zero Touch processing or Process improvement/simplification activities. Support inspections and audits as needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in life sciences or medically related field or previous experience equating to educational requirements 4+ years' experience in Pharmacovigilance or Medical information, Experience working with Vendors, Safety Case Processing and Argus System knowledge. Experience with Pharmacovigilance or Medical Information Call Center processes Experience in working with global service providers/vendor management Preferred Qualifications: If you have the following characteristics, it would be a plus: Cultural awareness and excellent global communication skills Awareness of GSK local operating company governance model. Ability to drive implementation of process improvements. Ability to resolve issues, and conduct investigations including root cause analysis. Experience with Spotfire dashboards Experience with data analytics and trending analysis Experience with Project management tools 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness 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. 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