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At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Our Mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine in our four core therapy areas of Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience, plus Plasma-Derived Therapies (PDT) and Vaccines.
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The Patient Safety Manager is responsible for overseeing the Pharmacovigilance function and providing functional expertise and support to the Local Operating Companies (LOCs) and applicable cross-functional engagements. In partnership with Global Patient Safety Evaluation and appropriate PV service providers, the role will ensure that the appropriate systems and processes are in place. The Patient Safety Manager position requires effective leadership and excellent communication to meet the needs of the business and to ensure compliance with applicable legislation and company procedures—locally, regionally and globally where Takeda holds MAH / marketed products.
Overall responsibilities include:
- Manage PV relationship within each Local Operating Company (LOC) to provide best PV support and functional expertise to the LOCs within the assigned territory, where applicable.
- Ensure compliance to applicable local legislations, company standards and procedures.
- Collaborate and liaise with Area Lead and other Global Patient Safety & Evaluation (GPSE) functions to ensure appropriate systems and processes are in place to support the local PV system.
- In partnership with Area Lead defines and implements the local PV strategies as appropriate.
Operational Excellence and Compliance
- Manage and oversee PV system and operational performance in accordance with local legislation and company requirements.
- Establish and support local and regional PV suppliers such as local resident QPPV suppliers and PV services suppliers as required, including establishing appropriate oversight of such suppliers.
- Ensure overall compliance to applicable GPSE standards and procedures, which may include but are not limited to conducting ICSR reporting and submissions, training management and compliance.
- Collaborate with Area Lead, GPSE and applicable stakeholders in the preparation and update of PV Agreements, risk management monitoring and implementation, and other relevant PV activities.
- Proactively identify gaps and process improvement opportunities. Implement corrective actions / preventive actions while ensuring inspection / audit readiness.
- Communicate all potential safety issues within the assigned territory immediately to GPSE, PVAR Liaison and Area Lead as appropriate.
- Perform local QPPV and local PV contact person activities where required.
Strategy, Communication and Management
- Serve as SME of the assigned territory and provide PV support and expertise to LOC activities in alignment with local legislation and company requirements, i.e. market research programs, patient assistance / support programs, named patient and compassionate programs, and investigator initiated trials.
- Ensure audit / inspection readiness within the assigned territory and, with support from GPSE and Area Leads, lead and participate in pre-, on-site and post-PV audit / inspections.
- Lead and implement applicable global, regional and local PV strategies in collaboration with Area Lead and serve as a liaison in the assigned territory between LOC functional units, GPSE and R&D.
- Develop effective and constructive working relationships and support stakeholders and crossfunctional engagements (i.e. Commercial, Legal, Medical Affairs, Regulatory Affairs, Quality Assurance and Supply Chain) to meet business needs.
- Ensure effective communication with all relevant internal and external key stakeholders.
- Effective budget control and resource management.
- Achieve functional objectives through development, management and engagement of team members.
- Establishe clear goals and performance metrics.
As with all Takeda positions, the Patient Safety Manager is expected to conduct themselves in line with the Company culture and values. Essential Skills and Qualifications Education and Experience
- Health professional or life science degree.
- Bachelor’s required. Advanced degree preferred.
- Relevant pharmaceutical or health care related industry experienced required.
- Meets all applicable local QPPV / PV contact person requirements including education, training, experience.
- Advanced experience, generally with at least 5 ears in PV related environments, preferably at local, regional and/or global levels.
- Understanding of medical and scientific terminology.
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation.
- Experience working within virtual teams.
- Excellent written and oral communication skills in local language and English.
- Accuracy and attention to detail.
- Ability to prioritize under pressure.
- Decision making capability, and ability to independently resolve problems and conflicts.
- Flexible mindset.
- High degree of cross-cultural awareness.
- Team worker with collaborative approach.
- Well-developed organizational skills.