Work closely with Takeda PSMF expert, provide back-up for PSMF expert and being part of Takeda EU QPPV office meeting objectives for GPSE.
Maintenance, development, production and distribution of the Takeda Pharmacovigilance System Master File (PSMF), including non-European versions (as required).
Monitor performance / compliance, training, the conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and EU GVP.
Ensure the company meets its legal obligation pertaining to EU regulation for the monitoring of the products with a marketing authorization in the EEA through working with the groups involved with Global Compliance and Standards, Global Regulatory Affairs, Quality Assurance and the LOC management function.
Ensures success of integration activities for the Takeda PV systems.
Under leadership of EUQPPV, coordinate building up an international QPPV network for the company and working alongside PV Affiliate Relations function.
Participate in integration activities for the EUQPPV office, working closely and as back-up for PSMF expert.
Supporting the integration of PSMFs for Takeda.
Evaluate and monitor internal / external compliance metrics.
Alert management, including EUQPPV, of significant deficiencies in quality or compliance standards including proposed corrective / preventative actions.
Ensures Pharmacovigilance compliance based on expectations and / or requirements of regulatory agencies, internal processes, and external business partner obligations.
Helps maintain PSMFs. Interacts with contributing functions to improve and enhance the final output of PSMF. Ensure the PSMF compliance with regulations including readiness to submit within required timelines.
Supports EUQPPV responses and corrective and preventative action plans (CAPAs) to audit / inspection findings for adequacy and timeliness, reviews implementation, and supports the close out of all corrective and preventative actions.
Support business partner audits and QA audits of business partners relevant to EUQPPV.
Provides support prior to, during and after regulatory inspections in EEA.
Work with Key internal and external stakeholders to define and ensure compliance with global business and regulatory requirements.
Work with PSMF expert on responsibility for PSMF procedural documents and participate / support in the revision and / or authoring process of other key procedural documents as required.
Other tasks as assigned.
Supports building up and international QPPV network for Takeda in conjuction with other sub-functions of GPSE
Education and Experience Requirements
Key Skills, Abilities, and Competencies
Complexity and Problem Solving
understand when procedural initiation and updates are required; and maintain training programs that ensure compliance with global standards.
Internal and External Contacts
Internal Contacts include : GPSE Organization, EU QPPV and other QPPVs as required by law; Quality Assurance, Regulatory Affairs, R&D compliance personnel,
External Contacts include : Vendors, Distributors, Regulatory authorities as required
Other Job Requirements
May require travel both domestically and internationally.
PHYSICAL DEMANDS :
TRAVEL REQUIREMENTS :