Make your mark for patients
To strengthen our R&D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position of: Impact Quality Lead – Braine l’Alleud, Belgium
About the role
As 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.
You will work with
You 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.
What you will do
Pharmacovigilance System Support
1. Provides 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.
2. Provides 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).
3. Provide oversight to UCB patient centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies).
4. Reviews processes for data integrity and quality during signal detection and risk management activities.
5. Supports validation and control of PV electronic systems.
6. Ensures 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.).
PV SOP Management and Training
7. Provide guidance and support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices.
8. Stay updated on changes in pharmacovigilance regulations, guidelines, and industry trends to ensure ongoing compliance and proactively address emerging requirements.
9. Ensures targeted training programs on GVP, regulatory expectations, and quality principles are delivered
Partner/Vendor Oversight
10. Provides critical oversight of PV partners/vendors to ensure efficient, consistent, and compliant pharmacovigilance activities. Monitors contract compliance, quality and timeliness of deliverables.
11. Interacts with clinical and pharmacovigilance vendors to ensure compliance with GCPs and GVPs and relevant country regulations.
Audits and Inspections
12. Hosting of PV audits and inspections.
13. Supports audit and inspection findings by developing and implementing effective remediation plans.
Compliance Monitoring
14. Leads mitigation efforts with key stakeholders (PV, Safety, Regulatory, and Clinical teams) to ensure alignment on quality standards and compliance requirements.
15. Monitors 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.
16. Review and monitor vendor compliance through various reports and oversight activities, including tracking KPIs, metrics, and quality control checks.
17. Participating in Pharmacovigilance specific Governance meetings.
18. Identifies, tracks, trends, and communicates PV compliance activities to senior management.
Deviation Management and Risk Management
19. Initiates deviations from discovery, ensures management and root cause analysis, and tracks CAPA implementation, and evaluates effectiveness.
20. Establishes processes to identify, assess, and mitigate risks related to pharmacovigilance activities.
21. Collaborate with cross-functional teams to address quality and compliance-related issues and drive process improvement initiatives.
Interested? For this position you’ll need the following education, experience and skills
22. Bachelor’s degree, preferably in Science or Engineering.
23. 12+ years of experience in GVP Quality Assurance, GVP Auditing, Pharmacovigilance, or a related field within the pharmaceutical, biotechnology, or healthcare industries.
24. Fluent English communication (oral and written); any additional languages are a plus.
25. Proven experience in supporting/leading GVP audits, regulatory inspections, and providing GVP quality management system support.
26. Strong global knowledge and understanding of local and international regulations applicable to the conduct of clinical trials and pharmacovigilance operations (GVPs, ICH guidelines, FDA, MHRA).
27. Strong analytical, problem-solving, communication, and decision-making skills.
28. Strong commitment to ethical standards,
29. Develops trustful relationships with internal and external stakeholders to accelerate business achievements.
30. Takes initiatives and works towards delivering results. Takes courageous decisions and balanced risks to create value for patients and UCB.
31. Ability to anticipate, influence & apply GVP regulations to ensure effective interpretations that support decision-making on current and future solutions to improve patients’ lives.
32. Ability 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.
Are 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!