StellenbeschreibungpbMake your mark for patients /b /ppTo strengthen our bRD and Pharmacovigilance Quality /bdepartment we are looking for a talented profile to fill the position of: bImpact Quality Lead – Bulle, Switzerland /b /ppbAbout the role /b /ppAs Impact Quality Lead you will be part of the with the Impact Quality team within RDPVQ. The Impact Quality Lead is a global role responsible for implementing and maintaining a balanced, proactive, global approach to pharmacovigilance (PV) compliance. This position is primarily responsible for ensuring PV activities are conducted in accordance with applicable global regulatory requirements, guidelines, polices, procedures and industry best practice. /ppbYou will work with /b /ppYou will collaborate closely with UCB cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization, Affiliate Offices, Clinical Operations, Regulatory Affairs, Commercial teams, etc. Key responsibilities include overseeing the pharmacovigilance system and pharmacovigilance quality system and providing oversight to Phase IVs studies and post-marketing commitments. /ppbWhat you will do /b /ppPharmacovigilance System Support /pliProvides expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) global regulatory expectations (FDA, EMA, ICH), and industry best practices to ensure compliance and operational excellence. /liliProvides support to Phase IV study types (i.e. Non-Interventional Studies, Compassionate Use, Surveys, Managed Access Programs, Named Patient Programs, Patient Centered Outcomes Research, Registries). /liliProvide oversight to UCB patient centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies). /liliReviews processes for data integrity and quality during signal detection and risk management activities. /liliSupports validation and control of PV electronic systems. /liliEnsures PV outputs are compliant including individual case safety reports (ICSRs), development safety update report (DSURs), Risk Management Plan (RMPs), and Risk Evaluation and Mitigation Strategies (REMS), etc.). /lipPV SOP Management and Training /pliProvide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices. /liliStay updated on changes in pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance and proactively address emerging requirements. /liliEnsures targeted training programs on GVP, regulatory expectations, and quality principles are delivered /lipPartner/Vendor Oversight /pliProvides critical oversight of PV partners/vendors to ensure efficient, consistent, and compliant pharmacovigilance activities. Monitors contract compliance, quality and timeliness of deliverables. /liliInteracts with clinical and pharmacovigilance vendors to ensure compliance with GCPs and GVPs and relevant country regulations. /lipAudits and Inspections /pliHosting of PV audits and inspections. /liliSupports audit and inspection findings by developing and implementing effective remediation plans. /lipCompliance Monitoring /pliLeads mitigation efforts with key stakeholders (PV, Safety, Regulatory, and Clinical teams) to ensure alignment on quality standards and compliance requirements. /liliMonitors regulatory submissions related to on-time delivery of ICSRs (to global Health Authorities, partners, including SUSAR and SAE communication to Ethic Committees and investigators as applicable) as well as the on-time submission of aggregate reports. /liliReview and monitor vendor compliance through various reports and oversight activities, including tracking KPIs, metrics, and quality control checks. /liliParticipating in Pharmacovigilance specific Governance meetings. /liliIdentifies, tracks, trends, and communicates PV compliance activities to senior management. /lipDeviation Management and Risk Management /pliInitiates deviations from discovery, ensures management and root cause analysis, and tracks CAPA implementation, and evaluates effectiveness. /liliEstablishes processes to identify, assess, and mitigate risks related to pharmacovigilance activities. /liliCollaborate with cross-functional teams to address quality and compliance-related issues and drive process improvement initiatives. /lipbInterested? For this position you’ll need the following education, experience and skills /b /pliBachelor’s degree, preferably in Science or Engineering. /lili12+ years of experience in GVP Quality Assurance, GVP Auditing, Pharmacovigilance, or a related field within the pharmaceutical, biotechnology, or healthcare industries. /liliFluent English communication (oral and written); any additional languages are a plus. /liliProven experience in supporting/leading GVP audits, regulatory inspections, and providing GVP quality management system support. /liliStrong global knowledge and understanding of local and international regulations applicable to the conduct of clinical trials and pharmacovigilance operations (GVPs, ICH guidelines, FDA, MHRA). /liliStrong analytical, problem-solving, communication, and decision-making skills. /liliStrong commitment to ethical standards, /liliDevelops trustful relationships with internal and external stakeholders to accelerate business achievements. /liliTakes initiatives and works towards delivering results. Takes courageous decisions and balanced risks to create value for patients and UCB. /liliAbility to anticipate, influence apply GVP regulations to ensure effective interpretations that support decision-making on current and future solutions to improve patients’ lives. /liliAbility to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations. /lipAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! /p
