Safety Specialist
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Job Summary
Make your mark for patients
患者さんのためにあなたの力を発揮してください
Primary Purpose / Regulatory Responsibilities:
Collaborate with the Process Management Team members and the Product Management Team members to ensure Safety communication and product stewardship
Ensure Pharmacovigilance systems operations and procedures are in place within the local organization for all territories assigned to the Affiliate
Key Contributor within the broader Patient Safety and/or Development Japan
MAJOR RESPONSIBILITIES
Pharmacovigilance System
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 teams to ensure that local obligations are managed and compliance with 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 (Als) 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.
Identify plan and implement key projects to improve quality reduce costs and increase productivity by reducing wasted time scrap rework etc. resulting in significant business improvement
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)
Product Stewardship
Ensure that 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 & contribute in product launch strategic meetings and ensure implementation of safety reporting related activities such as vendor qualifications GxP assessments training etc.
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 lead to solutions for patients
As a team member to ensure that Pharmacovigilance systems operations and procedures are in place within the local organization for all territories assigned to the Affiliate Japan
EDUCATION & QUALIFICATION
Bachelors Degree
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)
患者さんのために価値を創造しあなたの力を発揮してその先に進む準備はできていますかもしそう思われるならぜひご応募ください
UCBについて
UCBは神経学と免疫学に特化したグローバルなバイオ医薬品企業ですUCBは世界各地に約8500人の従業員を擁し患者さんに触発され科学を原動力としています
UCBで働く理由
UCBでは単に仕事をこなすだけでなく価値を創造します私たちは患者さんのために前進し協力し革新することを恐れませんUCBには思いやりがあり協力的な社風がありますそこでは誰もが仲間とともに尊重されベストを尽くす機会を公平に与えられています私たちは患者さん従業員地球のいずれに対しても常に人間的な視点に立ち患者さんのために価値を創造するその先を目指しますUCBで働けば自分が成長できる場所を発見し自分の可能性を最大限に発揮するために自分のキャリアパスを切り開く自由を得ることができます
UCBにおけるサステナビリティとそれが私たちのビジネスアプローチにどのように統合されているかについてはこちらをご覧ください
UCBとその子会社は職場における多様性と包括性を奨励しています人種肌の色宗教性別国籍退役軍人障害年齢性的指向性自認による差別は行いません
あなたの強みや能力を発揮するために日本での職種への応募に特別な配慮が必要な場合は までご連絡くださいその他のお問い合わせの場合このルートではサポートできませんのでご注意ください
Required Experience:
IC
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more
