Safety Associate

ジョブ番号: 973

外部説明:

Pharmacovigilance System
•    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 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.

Safety communication
•    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
•    Champion the coordination and enable effective safety communication to HAs/HCPs and patients and ensure
appropriate follow-up

Product Stewardship
•    Manage all information relevant to the benefit/risk balance of the UCB products is reported to Patient Safety (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

Patient Support Programs/Market Research programs/Digital initiatives
•    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

Proactive Regulatory Intelligence
•    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 relevant stakeholders. 

Health Authority inspections and Audit readiness
•    Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety 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);

Stakeholder Management
•    Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance; 
•    Engage external stakeholders e.g. scientific community, patient advocacy groups, regulators and pharma industry for insights that leads to solutions for patients.

 

Education Level

 

Required 

:   Bachelor's Degree

:   Other : HCP based education (e.g. physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area e.g. PhD/Master in biological sciences or related degree)

 

Experience

• 2-5 years Pharmacovigilance in a pharmaceutical environment (preferred multinational)

• Scientific background in Central Nervous System and/or Immunology therapeutic areas helpful

• Experience in a leadership role helpful

 

Competencies
Refer to PS competencies on UCB Plaza- PS Competencies for the profile of ‘International Pharmacovigilance’

Specific Skills (Include specific skills and knowledge necessary to meet the objectives of the position)
•    Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements 
•    Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to aim for 
100 % compliance;
•    Have strong interpersonal skills, especially in individual leadership and adaptability.
•    Team working and networking promoter
•    Strategic leadership, qualities of authenticity, resilience and adaptability
•    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, Pharma industry associations.
•    Excellent verbal and written communication in English. 
•    Demonstrated ability to understand, analyze, and summarize scientific and medical information.
•    Professional demeanor, team orientated, self-motivated, and ability to influence stakeholders both externally and internally.  
•    Problem solving: 
a.    Solid foundation for making quick, sound decisions, based on limited information

ジョブ番号: 973

コミュニティステータス: Safety Associate

Location_formattedLocationLong: Tokyo, Tokyo JP