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Reporting to Director of Safety Operations, this role act as lead for execution of Pharmacovigilance (PV) operational activities for the Global Mundipharma Organization.
Drives efficient management and delivery of all aspects of Local operational activities aligned with vision of centralizing and globalizing Mundipharma Pharmacovigilance system and processes.
Drives efficient management and delivery of all aspects of Local operational activities aligned with vision of centralizing and globalizing Mundipharma Pharmacovigilance system and processes.
Responsible for providing PV Operations leadership within the geographic cluster for conducing local oversight for all activities in all relevant territories including the development and maintenance of operational documents (SOPs and Work Instructions) and contributes to Safety Management Plans
Responsible for management and oversight of the Global Single Intake vendor responsible in the relevant territories for executing local operational activities including but not limited to:
- Case management
- Local Literature monitoring
- PV training
Responsible for monitoring compliance and performance metrics and monitors quality and timely delivery of safety outputs by the single global intake vendor
Act as the contact person for audits/Inspections and ensures inspection and audit readiness for PV operational matters
- Works with Quality Assurance (QA) to maintain an inspection readiness state
A member of global safety team supports the Safety organizations in fulfilling global pharmacovigilance requirements.
- Responsible for escalating issues related to Safety operations to the Director of Safety Operations and EEA QPPV, where appropriate.
- Drives efficient and effective delivery of PV Operational activities.
Participate in global improvement processes impacting Global Safety Organization
