Consumer Healthcare Regional PV Lead - Americas
Site Name: USA - New Jersey - Warren Posted Date: Oct 13 2021 Are you energized by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this Regional Pharmacovigilance (PV) Lead LATAM and Americas (Latin America and Americas role could be an ideal opportunity to explore. This is a new role in the Consumer Health Organisation. A regional PV Operating model is required to ensure fit for purpose PV compliance in line with local and global regulations for the CH portfolio (medicines, medical devices, cosmetics & dietary supplements. Three regionally dispersed teams will be in place to oversee and comply with PV activities in each country within that region. Each Region will have one lead who will be accountable for PV activities for all markets within that region. This role will be accountable for all of LATAM and Americas region. The role will be the Person Responsible for PV in the US and point of contact with FDA, including for PV inspections. The LATAM & Americas Pharmacovigilance Lead will provide leadership and manage the LATAM & Americas PV team which will be dispersed around the region.. The LATAM & Americas Pharmacovigilance Lead is accountable for the regional and local country oversight of pharmacovigilance activities, including the oversight of local PV activities outsourced to third parties. The role oversees all PV operational responsibilities carried out by the LATAM & Americas PV team throughout the region, as well as the Local Pharmacovigilance Responsible Persons (Local QPPVs and Local PV contacts, whether internal or outsourced) in ensuring regulatory compliance and business success with respect to pharmacovigilance obligations. Consumer Healthcare has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements. The LATAM & Americas Pharmacovigilance Lead ensures that activities are conducted in a fit-for-purpose manner appropriate for the products available in that region. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Act as Responsible person for PV in US and point of contact for FDA, including for PV inspections Responsible for establishing PV functions and providing guidance, support and ensuring compliance at the regional/country level Ensure visibility of PV compliance in the regions/countries through interaction with senior local/regional and global roles outside of the PV organisation and membership at Regional Lead team forums and governance boards. Escalate non-compliance in the region to the Head of Pharmacovigilance (PV) Operations Consumer Health Safety, EU QPPV and Head of CH Safety as appropriate Accountable for implementation of new regulations in their region by liaising with central/regional teams and third parties Ensure appropriate resources and capabilities are available in the team to meet and execute essential PV requirements to ensure that quality standards are met across the area and that best practice is shared and implemented Act as Responsible person for PV in US and point of contact for FDA, including for PV inspections Responsible for establishing PV functions and providing guidance, support and ensuring compliance at the regional/country level Ensure visibility of PV compliance in the regions/countries through interaction with senior local/regional and global roles outside of the PV organisation and membership at Regional Lead team forums and governance boards. Escalate non-compliance in the region to the Head of Pharmacovigilance (PV) Operations Consumer Health Safety, EU QPPV and Head of CH Safety as appropriate Accountable for implementation of new regulations in their region by liaising with central/regional teams and third parties Ensure appropriate resources and capabilities are available in the team to meet and execute essential PV requirements to ensure that quality standards are met across the area and that best practice is shared and implemented Work closely with the local/regional commercial and HR business partners in the selection, onboarding and training of LATAM & Americas PV team including local QPPVs/Local PV contacts Provide team leadership and ensure talent development and succession planning is in place for all key roles Drive risk-proportionate and fit for purpose approach for PV in the region whilst ensuring maximal operational efficiency whilst maintaining high standards of global PV compliance Understand the business model and risks in each country in the region and work closely with the commercial teams to ensure appropriate PV support is implemented Provide strategic direction for outsourced Local PVs 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. Work closely with the Head of PV Operations, the EU QPPV and other PV functional leaders to ensure alignment and consistent implementation of global processes, policies and procedures Point of contact and host for all inspections and audits in the region 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 in pharmacovigilance, clinical development, medical information or quality management area. Equivalent work experience considered Fluency in business English Essential Extensive experience in Pharmaceutical industry and related discipline - Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilance Leadership and managerial experience required Sound knowledge of regulatory guidelines and legislations, FDA, Health Canada, ICH, GCP Experience in CAPA Management, audit and inspection as the role will be point of contact for region in inspections Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree or prior experience as a local QPPV would be an advantage. Must have demonstrated people leadership capability (span and depth) Language skills are an advantage (Spanish and Portuguese) Excellent interpersonal, analytical, negotiation decision making influencing and problem-solving skills Excellent written and verbal communication skills Good level of computer literacy with Microsoft applications 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). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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