Ph3Impact Quality Lead – Braine l’Alleud, Belgium /h3 h3About The Role /h3 pAs Impact Quality Lead you will be part of 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, policies, procedures and industry best practice. /p h3You will work with /h3 pYou 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 IV studies and post‑marketing commitments. /p h3What You Will Do /h3 h3Pharmacovigilance System Support /h3 ul liProvides 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. /li liProvides 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). /li liProvide oversight to UCB patient centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies). /li liReviews processes for data integrity and quality during signal detection and risk management activities. /li liSupports validation and control of PV electronic systems. /li liEnsures 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. /li /ul h3PV SOP Management and Training /h3 ul liProvide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices. /li liStay updated on changes in pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance and proactively address emerging requirements. /li liEnsures targeted training programs on GVP, regulatory expectations, and quality principles are delivered. /li liProvides critical oversight of PV partners/vendors to ensure efficient, consistent, and compliant pharmacovigilance activities. Monitors contract compliance, quality and timeliness of deliverables. /li liInteracts with clinical and pharmacovigilance vendors to ensure compliance with GCPs and GVPs and relevant country regulations. /li /ul h3Audits and Inspections /h3 ul liHosting of PV audits and inspections. /li liSupports audit and inspection findings by developing and implementing effective remediation plans. /li /ul h3Compliance Monitoring /h3 ul liLeads mitigation efforts with key stakeholders (PV, Safety, Regulatory, and Clinical teams) to ensure alignment on quality standards and compliance requirements. /li liMonitors regulatory submissions related to on‑time delivery of ICSR 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. /li liReview and monitor vendor compliance through various reports and oversight activities, including tracking KPIs, metrics, and quality control checks. /li liParticipating in Pharmacovigilance specific Governance meetings. /li liIdentifies, tracks, trends, and communicates PV compliance activities to senior management. /li /ul h3Deviation Management and Risk Management /h3 ul liInitiates deviations from discovery, ensures management and root cause analysis, and tracks CAPA implementation, and evaluates effectiveness. /li liEstablishes processes to identify, assess, and mitigate risks related to pharmacovigilance activities. /li liCollaborate with cross‑functional teams to address quality and compliance‑related issues and drive process improvement initiatives. /li /ul h3Interested? For this position you’ll need the following education, experience and skills /h3 ul liBachelor’s degree, preferably in Science or Engineering. /li li12+ years of experience in GVP Quality Assurance, GVP Auditing, Pharmacovigilance, or a related field within the pharmaceutical, biotechnology, or healthcare industries. /li liFluent English communication (oral and written); any additional languages are a plus. /li liProven experience in supporting/leading GVP audits, regulatory inspections, and providing GVP quality management system support. /li liStrong global knowledge and understanding of local and international regulations applicable to the conduct of clinical trials and pharmacovigilance operations (GVPs, ICH guidelines, FDA, MHRA). /li liStrong analytical, problem‑solving, communication, and decision‑making skills. /li liStrong commitment to ethical standards. /li liDevelops trustful relationships with internal and external stakeholders to accelerate business achievements. /li liTakes initiatives and works towards delivering results. Takes courageous decisions and balanced risks to create value for patients and UCB. /li liAbility to anticipate, influence apply GVP regulations to ensure effective interpretations that support decision‑making on current and future solutions to improve patients’ lives. /li liAbility 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. /li /ul pWe have a hybrid‑first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. /p pUCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. /p pShould you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. /p /p #J-18808-Ljbffr