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At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Pharmacovigilance department in Northern Europe , we are looking for a talented individual to be based in Copenhagen, Denmark to fill the position of:
Scandinavia Safety Leader
As the Scandinavia Safety Leader you are accountable for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate: Denmark, Norway and Sweden. You are the primary contact for pharmacovigilance at the Affiliates in Denmark, Norway and Sweden.
You like to work in an environment where you can: Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance Champion the coordination and enable effective safety communication to HAs/HCPs and patients and ensure appropriate follow-up
You willcontribute by (including but not limited to): Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Patient Safety; Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations (UCB colleagues or third parties); Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements; Work in close collaboration with corporate Patient Safety and Medical Management teams to ensure that local obligations are managed and compliance to local authorities is maintained; Provide input into global/local processes to secure compliance; Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order 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 as appropriate. Collaborate in true partnership with business units in programs leading to solutions for patients plus ensure compliant set up and oversight; Proactive assessment of the capability and capacity of PSP/MRP vendors to conduct critical pharmacovigilance tasks (in support of qualification audits) and avoid issues of regulatory compliance; Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to corporate teams (including EEA QPPV), local stakeholders; Perform Impact assessment, gap analysis and implementation strategy for new or updated regulations and notify the EEA QPPV, corporate Patient Safety and Medical Management and relevant stakeholders. Knowledge of product safety risks to act proactively and independently with local stakeholders (e.g. DHCP letter) and proactively escalate local safety issues to the Safety Leads as appropriate; Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Medical Management and Quality Assurance; Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective Actions Preventive Actions (CAPAs); Ensure that all information relevant to the benefit/risk balance of the UCB products is reported to Patient Safety and Medical Management (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation; Provide input into the Risk Management Strategy as needed to secure local compliance; Act as local Subject Matter Expert on product safety, contributing to the product lifecycle activities, product information (e.g. labelling review) and risk management e.g. recalls, DHCP letters, implementation of Risk Management Plan as applicable; Participate in product launch strategic meetings and ensure safety related reporting trainings Engage external stakeholders e.g. scientific community, patient advocacy groups, regulators and pharma industry for insights that leads to solutions for patients. Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training; Ensure that a pharmacovigilance training is provided to any local UCB employees and applicable Vendors as applicable; Ensure that the local Safety organizational charts are kept current and any changes in the local staff are communicated to corporate Patient Safety.
Interested? For this position you’ll need the following education, experience and skills: Bachelor’s degree (life sciences, HCP based education (such as physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area; 5 years in Pharmacovigilance at minimum. Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements; Scientific background in Central Nervous System and/or immunology therapeutic areas helpful; Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives in order to aim for 100 % compliance; Have strong interpersonal skills, especially in the area of individual leadership and adaptability; Ability to lead and motivate and influence in matrix organizations at the Affiliate; Team working and networking promoter; Strategic leadership, qualities of authenticity, resilience and adaptability; High level of integrity and honesty, both internally and externally. Able to inspire direct team and others; Excellent oral and written communication skills as the individual in this position will be interacting with multiple levels and diverse functions (e.g. commercial, quality, regulatory, legal, medical) within and outside UCB (e.g. regulators, patients, HCP’s, Pharmaindustry associations); Excellent verbal and written communication in English (specify any local language skills according to local requirements, if any); Demonstrated ability to understand, analyze, and summarize scientific and medical information; Problem solving skills.
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