Patient Safety Lead

Job Description

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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

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