Consumer Healthcare Head of Pharmacovigilance Operations

Company: GlaxoSmithKline
Location: Warren
Posted on: June 6, 2021

Job Description:

Site Name: USA - New Jersey - Warren Posted Date: May 28 2021 Are you energized by a highly visible pharmacovigilance role that optimizes safety and risk management standards on a global scale? If so, this Head of Pharmacovigilance (PV) Operations role could be an ideal opportunity to explore. Head of Pharmacovigilance (PV) Operations leads a team of approximately 50 within the Consumer Health Global Safety team and is accountable for driving and implementing the strategic direction of the function and overseeing day-to-day operational activities. In scope activities include but are not limited to: Individual Case Safety Report (ICSR) Processing: end-to-end activities linked directly or indirectly to case processing (intake to expedited reporting), including central oversight of PV activities provided by the end to end case processing outsourcing partner. Alliance Management: PV contract management activities related to the set-up, maintenance and oversight of safety data exchange agreements (SDEAs) with license partners, and maintenance of AE clauses for third party contracts. Literature: PV activities related to the review and identification of ICSRs and articles of interest in published scientific literature. Regional and local PV activities, including the oversight of any Country/Regional outsourcing partner. In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special. This role reports directly to Global Head of Consumer Health Safety and will be a member of the CH Consumer Safety Leadership Team Lead operational teams in the Global Safety organization that are responsible for the full ICSR lifecycle management (including literature screening and processing), Alliance Management (PV Contracts) and Regional/Local Operating Country (LOC) model Responsible for implementing strategic initiatives, including insourcing/outsourcing, that are aligned with company priorities across the PV operations teams Proactively address and manage risks related to PV operations activities (including local QPPVs), with appropriate issue escalation Accountable for the oversight of supplier services (including ICSR lifecycle management and country/regional vendors) to ensure service level agreements (SLAs) are met, compliance and quality thresholds are measured, and that training delivery is optimized to ensure a robust service delivery model Ensure that appropriate Key Performance Indicators (KPIs) and metrics are provided to senior management, including the EU QPPV to allow for appropriate monitoring of the PV system Ensure the PV operational system is aligned with a risk-proportionate approach for the CH portfolio that is compliant with changes in the global regulatory framework and consistent with company standards and legal/privacy obligations Establish a lean PV operational model with consideration for innovative, cost-effective and fit-for-purpose solutions Accountable for GxP related audits and inspections for PV Operations and country / regional PV activities, including corrective and preventive actions (CAPAs) Ensure consistency of process and flow of communication between all parties involved in managing the PV System including but not limited to other PV functions / Third parties / countries Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in a scientific or medically-related field, plus demonstrated leadership experience in the pharmaceutical industry, particularly in senior operational roles. Equivalent work experience considered Significant operational experience across pharmacovigilance, materiovigilance, cosmetovigilance & nutrivigilance. Strategic and tactical mindset to meet the objectives of the Global Safety Leadership Team and company initiatives Experience with managing team budgets and resource allocations Demonstrated experience with PV contract management/ SDEAs Strong experience in CAPA Management, audit and inspections Proven experience working directly with outsourced providers Practical knowledge of relevant worldwide regulations for all product types, e.g. Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP/GPVP) requirements, materiovigilance, cosmetovigilance, nutrivigilance. Preferred Qualifications: If you have the following characteristics, it would be a plus: Additional qualification Masters/PhD or qualifications in Pharmacovigilance would be an advantage. Must have demonstrated people leadership capability (span and depth) Excellent communication skills and the ability to effectively contribute and liaise with senior leadership teams Experience in managing/working with Local PV QPPVs preferable Effective leadership skills to manage numerous direct and indirect reports across a global landscape with consideration to cultural diversity 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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). 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Keywords: GlaxoSmithKline, Elizabeth , Consumer Healthcare Head of Pharmacovigilance Operations, Other , Warren, New Jersey