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Job Description
OBJECTIVES:
Manage pharmacovigilance (PV) activities and according to LOC/Cluster requirements
Partner with the PV Country Lead to ensure that systems and processes support regulatory compliance effectively
Provide PV expertise and support to local operating company (LOC)
Collaborate with LOC/PSPV colleagues and internal/external key partners, where applicable
Act as the Deputy of the PV Country Lead concerning all PV activities
ACCOUNTABILITIES:
In collaboration with the PV Country Lead, manages PV activities, including but not limited to:
Ensure compliance to all applicable Global and local PV processes and regulations
Ensure audit/inspection readiness at all times
Support the development and implementation of necessary processes, systems and tools for the handling of local PV activities, as per assigned responsibilities
Support local and global PV strategies and implementation at LOC level, as per assigned responsibilities
Act as SME, as per assigned responsibilities and as it relates to applicable local and global regulatory requirements, resourcing, compliance and other factors
Establish appropriate oversight of vendors/suppliers, as required
Monitor local Risk Management Plans (RMPs) and risk minimization activities relevant for the territory
Monitor or oversee Market Research (MR) and/or Patient Support Programs (PSPs) conducted at the LOC to ensure safety information is managed appropriately
Where applicable, review protocols for local studies and define PV related processes for local study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standards
Work with PSPV global colleagues and the EU QPPV office as applicable to implement any strategies related to EU and local/regional requirements
Engage with key local internal stakeholders, including Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial teams, and external stakeholders (vendors, partners) with PV obligations, agreements, etc.
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 PSPV worldwide team and represent our PSPV function inside and outside of the company, as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Health professional or life sciences degree (Bachelor's required; advanced degree preferred)
Minimum of 5 years' advanced experience in pharmacovigilance or related environments, with adjustments based on country/regional requirements
Advanced experience of working cross-functionally, preferably in R&D companies.
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 language and English) and experience working within virtual teams
Leadership skills
Excellent collaborative and organizational skills
Flexible mindset
High standard of computer literacy
Execute good documentation practices
Accuracy and attention to detail
Locations
Madrid, Spain
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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