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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. Acts as a backup or primary contact for pharmacovigilance at the Affiliate and supports the operational management of local safety officers.

Responsibilities

• Implement and maintain a pharmacovigilance system for UCB products authorized in the territory and ensure compliance with applicable 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 ensure local obligations are managed and compliance to local authorities is maintained.
• Maintain quality management system related to pharmacovigilance, including management of 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 by defining appropriate CAPAs and ongoing trend analysis.
• Maintain a functional connection with the Qualified Person for Pharmacovigilance (Global/EEA QPPV).
• Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office.
• Ensure that adequate back-up processes are available.
• Maintain thorough knowledge of local current pharmacovigilance regulatory requirements and landscape.
• Proactively monitor for emerging regulations and communicate such to corporate teams and local stakeholders.
• Perform Impact assessment, gap analysis and implementation strategy for new or updated regulations.
• Notify Global/EEA QPPV, corporate Pharmacovigilance and relevant stakeholders of new or updated regulations.
• Ensure inspection and audit readiness of relevant local departments in collaboration with corporate Pharmacovigilance and Quality Assurance.
• Participate in and manage pharmacovigilance audits and inspections.
• Perform root cause analysis and ensure timely identification and implementation of CAPAs.
• Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance.
• Engage external stakeholders for insights that lead to solutions for patients.
• Support the LSO in operational management of 1-2 medium or 1 high complexity Affiliate/country.
• Collaborate as Deputy LSO for another country outside of direct Affiliate responsibility or another Affiliate.
• Act as back-up SME for other Affiliates/countries.
• Support effective management of Partnerships/vendors for at least 1 countries/Affiliates.

Requirements

• Requires both English and Japanese CVs for application.
• Expert in pharmacovigilance with in-depth knowledge of associated regulatory requirements.
• Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to meet compliance requirements.
• Good interpersonal skills and ability to work independently in matrix organizations.
• Promoter of team working and networking.
• Possesses qualities of authenticity, resilience, and adaptability.
• Communicates personal views clearly, even if opposed by others.
• Acts as a role model with high integrity and honesty, inspiring peers, stakeholders, and others.
• Excellent oral and written communication skills for interaction across multiple levels and diverse functions within and outside UCB.
• 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, 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 understanding the risks and precautions required.

Skills

• Pharmacovigilance
• Regulatory requirements
• Planning
• Organization
• Prioritization
• Task execution
• Interpersonal skills
• Independent work
• Matrix organizations
• Team working
• Networking
• Authenticity
• Resilience
• Adaptability
• Clear communication
• Integrity
• Honesty
• Inspiration
• Oral communication
• Written communication
• Meeting facilitation
• Scientific information analysis
• Medical information analysis
• Stakeholder engagement
• Problem solving
• Risk identification
• Solution proposal
• Gap analysis
• Trend analysis
• Risk mitigation
• Technology understanding

Location

• Local organization
• Affiliate

Work Type

• Full-time

Experience Level

• Medium complexity Affiliate/country
• High complexity Affiliate/country

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 focusing on neurology and immunology.
• Approximately 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, value creation is prioritized over simply completing tasks.
• The company embraces challenges, collaboration, and innovation to achieve results for patients.
• A culture of compassion and support exists where everyone is respected, accepted, and can do their best.
• UCB consistently aims for 'what's next', delivering human-centered value for patients, employees, and the planet.
• Working at UCB allows for personal growth, career development, and maximizing potential.

Equal Opportunity

• UCB values equal opportunity.
• All hiring decisions are made regardless of any legally protected attribute.
• Contact EMEA-Reasonable_Accommodation@ucb.com for accommodation during the selection process.