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About the Role

Responsible for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate as delegated. Serves as a backup or primary contact for pharmacovigilance at the Affiliate and supports the operational management of local operations.

Responsibilities

• Implement and maintain a pharmacovigilance system for UCB products authorized in the territory, ensuring compliance with regulatory and company requirements.
• Identify and articulate evolving local needs impacting Pharmacovigilance and collaborate with corporate teams to develop and implement solutions.
• Provide input to harmonize global/local processes and secure compliance.
• Work in collaboration with corporate Pharmacovigilance teams to manage local obligations and maintain compliance with local authorities.
• Maintain the quality management system related to pharmacovigilance, including SOPs, AIs, and documents.
• Perform gap analysis to ensure alignment with global SOPs.
• Maintain oversight of local deliverables delegated to service providers.
• Ensure timely management of deviations and risk mitigation through CAPAs and trend analysis.
• Maintain a functional connection with the Qualified Person for Pharmacovigilance (Global/EEA QPPV).
• Ensure local information for the Pharmacovigilance System Master File (PSMF) is available to the EEA QPPV office.
• Ensure adequate back-up processes are available.
• Maintain knowledge of local pharmacovigilance regulatory requirements and proactively monitor for emerging regulations.
• Communicate regulatory changes to corporate teams, local stakeholders, and the EEA QPPV.
• Perform impact assessment, gap analysis, and implementation strategy for new or updated regulations.
• Ensure inspection and audit readiness of local departments in collaboration with corporate Pharmacovigilance and Quality Assurance.
• Participate in and manage pharmacovigilance audits and inspections.
• Perform root cause analysis and implement CAPAs for audits and inspections.
• Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance.
• Engage external stakeholders, including the scientific community, patient advocacy groups, regulators, and the pharma industry, for insights that lead to solutions for patients.
• Support the LSO in operational management of local operations.
• Collaborate as Deputy LSO for other countries or Affiliates.
• Act as back-up SME for other Affiliates/countries.
• Support effective management of Partnerships/vendors for additional countries/Affiliates.

Requirements

• Expert in pharmacovigilance with in-depth knowledge of associated regulatory requirements.
• Ability to plan, organize, prioritize, and execute multiple tasks to meet compliance requirements.
• Good interpersonal skills and ability to work independently in matrix organizations.
• Promoter of team working and networking.
• Qualities of authenticity, resilience, and adaptability.
• Ability to communicate personal views clearly, even if opposed by others.
• High level of integrity and honesty, both internally and externally.
• Ability to inspire peers, stakeholders, and others.
• Excellent oral and written communication skills for interaction across multiple levels and diverse functions.
• Excellent verbal and written communication in English and local language as required.
• Good meeting preparation and facilitation skills.
• Demonstrated ability to understand, analyze, and summarize scientific and medical information.
• Professional demeanor, team-oriented, self-motivated, and ability to effectively engage with stakeholders.
• Experience and ability to identify risks or issues and propose solutions or alternatives.
• Ability to identify gaps, perform trend analysis, and implement risk mitigation strategy.
• Ability to understand and use technology, knowing its limitations and associated risks and precautions.

Skills

• Pharmacovigilance
• Regulatory requirements
• Planning
• Organization
• Prioritization
• Task execution
• Compliance management
• Interpersonal skills
• Independent work
• Matrix organization navigation
• Teamwork
• Networking
• Authenticity
• Resilience
• Adaptability
• Clear communication
• Integrity
• Honesty
• Inspiration
• Oral communication
• Written communication
• Meeting facilitation
• Scientific information analysis
• Medical information analysis
• Information summarization
• Professional demeanor
• Stakeholder engagement
• Problem solving
• Risk identification
• Issue identification
• Solution proposal
• Trend analysis
• Risk mitigation
• Technology understanding

Location

• Local organization
• Affiliate

Work Type

• Full-time

Experience Level

• Expert

Education Level

• Bachelor's Degree
• HCP based education (such as physician, pharmacist, nurse)
• Any relevant graduation/experience in medical-scientific area (such as PhD/master in biological sciences or related degree)

About the Company

• UCB is a global biopharmaceutical company focused on the neurology and immunology fields.
• Approximately 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, we value creating value, not just doing work.
• We strive to embrace challenges, collaborate, and innovate to deliver results for patients.
• We foster a caring and supportive culture where everyone is respected, accepted, and has an equal opportunity to do their best.
• We are always looking 'beyond' to deliver human-centered value for patients, employees, and the planet.
• Working at UCB allows you to grow, build your career freely, and reach your full potential.

Equal Opportunity

• UCB values equal opportunities.
• All hiring decisions are made regardless of any legally protected attribute.
• If you require special accommodations during the selection process to showcase your strengths and abilities, please contact EMEA-Reasonable_Accommodation@ucb.com.