Pharmacovigilance Cluster Lead, Gulf, Patient Access and Safety Lead
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Job Description
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Local Patient Safety Lead
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You will manage and lead local pharmacovigilance (PV) activities and responsibilities across the assigned countries within the Gulf Local Operating Cluster, in accordance with local regulatory requirements and company standards. You will provide PV expertise and support to the local organization, collaborate with local and global Patient Safety and Pharmacovigilance (PSPV) teams and other internal and external partners, as needed, and partner with the PV Area Lead to implement local pharmacovigilance plans.
Where required and permitted by local legislation, you may also serve as the local Qualified Person for Pharmacovigilance (QPPV), local Safety Responsible, or deputy for these roles.
Global Patient Access and Safety Lead
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You will provide oversight and subject matter expertise for patient access programs and initiatives, helping to ensure compliance with pharmacovigilance systems and processes supporting Takeda’s patient access mechanisms. You will identify applicable pharmacovigilance legislation for patient access mechanisms, support related projects, and anticipate future needs to enable timely implementation of local pharmacovigilance activities in accordance with applicable requirements.
You will also lead and assign work to team members supporting operational pharmacovigilance activities for patient access mechanisms, maintain a strong connection with the Patient Safety & Pharmacovigilance Affiliate Management (PSPV-AM) Head, and provide relevant business updates related to patient access safety.
How You Will Contribute
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Local Patient Safety Lead
- Manage, support, and oversee the pharmacovigilance system within the assigned territory in accordance with local legislation and company requirements, including safety reporting and submissions, training, pharmacovigilance agreements and obligations, risk management plan implementation, cross-functional activities, organized data collection programs, PSMF updates and maintenance, Quality Management System (QMS) activities, vendor oversight, etc.
- Work closely with the regional PSPV-AM Liaison and PV Area Lead to support and coordinate local pharmacovigilance interactions with other PSPV teams.
- Maintain a network of relevant partners across Commercial, local organizations, and PSPV to support pharmacovigilance plans and help prevent gaps between Commerci...
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