Patient Safety Lead応募後で応募 求人ID R0021158 掲載日 07/08/2020 Location:Shanghai, China
- Collaborate and liaise with PVAR Country Lead and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system
- Provide Pharmacovigilance functional expertise and support to LOCs
- Manage the PV relationship within the local operating company (LOC) to provide best PV support for the LOC.
- In partnership with PVAR Country Lead, defines and implements the local PV strategies as appropriate
- Support PVAR Country Lead in the management of the PV system in the LOC which can include but is not limited to compliance to all applicable Global PV processes, commercial team engagements; PSP, MR, suppliers with PV obligations, agreements, PV training, supplier issues etc. This includes working with PV suppliers where appropriate and ensuring a common understanding of the distribution of PV responsibilities is in place.
- Works with PVAR Liaison to support Country Lead with implementing global, regional and local and cluster wide (where applicable) PV strategies at the LOC.
- Maintains appropriate stakeholder network with applicable Commercial BU, LOC 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.
- Ensure close collaboration with GPSE Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally to best support LOC needs.
- To be the SME of their assigned territory as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors.
- Establish / Support local PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers.
- Work with the Country Lead, Process and Compliance leads, Vendor Management/ Oversight personnel in support of LOC PV audits/inspections including follow-up and CAPA management.
- Embrace 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:
- Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical. Advanced degree preferred.
- 3 years or more PV working experience in the pharmaceutical or CRO industry, have a deep understanding of pharmacovigilance and local regulatory requirements & processes for the post marketing global environment.
- Excellent written/oral communication skills (local language and English) with proven ability to negotiate and communicate with internal and external stakeholders.
- Accuracy and attention to detail with flexible mindset
- Ability to handle multiple assignments and changing priorities.
- Team worker with collaborative approach.