About the Role
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The Impact Quality Lead falls within the Impact Quality team within R&D and Pharmacovigilance Quality. This position is a global role responsible for ensuring pharmacovigilance (PV) activities are conducted in accordance with applicable global regulatory requirements, guidelines, policies, procedures, and industry best practices.
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Your Key Responsibilities Will Include:
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* Providing 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.
* Supporting Phase IV study types (i.e., Non-Interventional Studies, Compassionate Use, Surveys, Managed Access Programs, Named Patient Programs, Patient Centered Outcomes Research, Registries).
* Providing oversight to UCB patient-centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies).
* Ensuring 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.
* Developing and executing a comprehensive and efficient Quality Assurance strategy for critical PV processes, aligning with SOPs and regulatory requirements.
* Monitoring compliance with global regulatory requirements by ensuring the implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level.
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What You'll Need to Succeed
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* Bachelor's degree in Life Sciences, Master's degree is a plus, with 8 – 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry.
* Proficiency in internal auditing, partner auditing, risk assessments, compliance monitoring, and inspection management activities preferred.
* Knowledge of GVP and GCP, and applicable regulatory frameworks.
* Ability to proactively identify, assess, and identify solutions to mitigate potential risks to the pharmacovigilance system.
* Ability to lead medium to high complexity projects.
* Excellent verbal and written communication skills in English.
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A Few Words About Us
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We're a global biopharmaceutical company focused on neurology and immunology. We're inspired by patients and driven by science. Our culture is caring, supportive, and inclusive, with equal opportunities for everyone to grow and succeed.
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Why Choose Us?
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We 'go beyond' to create value for our patients, and always with a human focus. Whether that's on our patients, our employees, or our planet, we strive to make a positive impact. We're committed to innovation, collaboration, and continuous improvement.
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Key Benefits
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We offer a dynamic work environment, exciting career opportunities, and a chance to be part of something bigger than yourself. If you're passionate about making a difference, we want to hear from you!