Patient Safety Lead応募後で応募 求人ID R0019467 掲載日 05/15/2020 Location:Tallinn, Estonia
- Supports Local Operating Companies (LOCs) within assigned cluster in collaboration and agreement with the appointed cluster lead.
- Performs local PV contact person activities where required in the cluster and trained to do so.
- Maintains Description of Pharmacovigilance Responsibilities to provide official record of Global Patient Safety Evaluation (GPSE) and assigned LOC(s) delegation of responsibilities.
- Manages PV system in the LOCs which can include but is not limited to compliance to all applicable Global PV processes, and supporting commercial team engagements (e.g. PSP, MR, suppliers with PV obligations, agreements, PV training). This includes working with PV suppliers where appropriate.
- Maintains appropriate stakeholder network with applicable Commercial Business Units, LOCs and R&D to facilitate implementation of GPSE strategy and serve as a liaison in their assigned territory to prevent gaps between Commercial BU, R&D functions and GPSE.
- To be the SME of their assigned territory as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors.
- Establishes / Supports local and/or regional PV suppliers (e.g. local resident QPPV/PV contact suppliers, PV services suppliers, including for business continuity) as required including establishing appropriate oversight of such suppliers.
- Works with GPSE to implement PV strategies at the LOCs. Support and facilitate LOC PV interactions with global departments and with other LOCs within the cluster.
- Ensures close collaboration with GPSE Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally to best support LOC needs. Works with stakeholders in support of LOC PV audits/inspections including follow-up and CAPA management.
- Embraces the Takeda cultural mind-set of “Patient, Trust, Reputation and Business” in the workplace, undertaking personal accountability to live these values as we work within our one GPSE worldwide team and represent our GPSE function inside and outside of the company, as appropriate.
EDUCATION, EXPERIENCE AND SKILLS
- Health professional or life science degree
- Relevant pharmaceutical or health care related industry experience required
- Advanced experience in PV related environments, preferably at local, regional and/or global levels (3-5 years preferred)
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
- Excellent written/oral communication skills (local language and English) and experience working within virtual teams.
- Advanced experience of working cross-functionally