Patient Safety LeadApply NowEmail Me Job ID R0021174 Date posted 07/06/2020 Location: Brussels, Belgium
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- Manage the PV relationship within the local operating company (LOC) to provide best PV support for the LOC.
- Supports LOCs within their Cluster, where applicable
- Collaborate and liaise with PVAR 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
- In partnership with PVAR defines and implements the local PV strategies as appropriate
- Manages 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 closely with the regional PVAR Liaison to support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the Cluster, where applicable.
- Works with PVAR to implement 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.
- 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 and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers.
- Support LOCs within assigned cluster (where applicable) in collaboration and agreement with the appointed cluster lead.
- Perform local QPPV and/or local PV contact person activities where required and trained to do so
- Line manage PV resources where appropriate
- Maintains Descriptions of Pharmacovigilance Responsibilities (DPRs) to provide official record of GPSE and LOC delegation of responsibilities.
- Work with Cluster Leads, Process and Compliance leads, Vendor Management/Oversight personnel in support of LOC PV audits/inspections including follow-up and CAPA management.
- Ensure close collaboration with GPSE Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally to best support LOC needs.
- Ensures all contact information and any changes of LOC PV personnel are maintained for GPV communications.
- 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.
SCOPE OF SUPERVISION:
No direct reports
EDUCATION, EXPERIENCE AND SKILLS:
- Health professional or life science degree
- Bachelor’s required. Advanced degree preferred.
- Relevant pharmaceutical or health care related industry experience required
- Meets all applicable local QPPV / PV Contact Person requirements including education, training, experience.
- Advanced experience in PV related environments, preferably at local, regional and/or global levels
- Advanced experience of working cross-functionally
- Understanding of medical/scientific terminology
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
- Excellent written/oral communication skills (local languages and English) and experience working within virtual teams
- Accuracy and attention to detail
- Flexible mindset
- High degree of cross-cultural awareness
- Team worker with collaborative approach.
- Ability to prioritize under pressure
- Well-developed organizational skills
- High standard of computer literacy
- Verbal and written proficiency in English, Dutch, and French
- Travel infrequently required likely <3 trips per year