Pharmacovigilance Country Lead, Thailand応募後で応募 求人ID R0100749 掲載日 07/07/2023 Location:Bangkok, Thailand
- Manage the PV relationship within the Local Operating Company (LOC) to provide best Pharmacovigilance (PV) support and functional expertise to the LOC(s) within the assigned territory(ies), where applicable
- Ensure compliance to applicable local legislations, company standards and procedures
- Collaborate and liaise with relevant PVAR Area Lead and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system. As such, the role requires effective leadership and partnership with the relevant stakeholders, both internally as externally
- The role requires effective leadership and day to day prioritization of pharmacovigilance (PV) tasks in order to meet the needs of the business and ensure compliance to all applicable local and global PV legislation and company procedures
- In partnership with PV Area Lead, defines and implements the local PV strategies as appropriate
- Where applicable, the PV Country Lead will also act as the local Qualified Person for Pharmacovigilance (QPPV) or Local Safety Responsible (LSR) as per the local applicable PV legislations
- Manages and oversees the PV system in the assigned territory(ies) in accordance with local legislation and company requirements which may include but not limited to conducting safety reporting and submissions, business continuity, trainings, PV agreements and obligations, risk management plan implementations, cross-functional engagements, organized data collection programs, PV vendor/supplier oversight and management. This may include working with PV suppliers where appropriate and ensuring a common understanding of the distribution of the PV responsibilities is in place
- Works closely with the regional PVAR Liaison and PV Thailand Lead to support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the assigned territory(ies), where applicable
- Maintains appropriate stakeholder network with applicable Leadership teams, Commercial BU, LOC and R&D to facilitate and implement GPSE strategies in collaboration with PV Thailand Lead, and serve as a liaison in their assigned territory(ies) to prevent gaps between Commercial BU, R&D functions and GPSE
- To be the SME of their assigned territory(ies) as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors
- Establish and support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers, if applicable
- With support from Regional Process and Compliance Lead, and PV Thailand lead, manage audit/inspection preparation and lead the audit/ inspection within the assigned territory(ies). Responsible for CAPA initiation and closure within the assigned territory(ies).
- Communicate all potential safety issues within the assigned territory(ies) immediately to GPSE, Region Head, PVAR liaison and PV Thailand Lead as appropriate.
- Support LOC(s) within assigned territory(ies), where applicable in collaboration and agreement with the appointed Cluster Lead.
- Perform local QPPV and/or local PV contact person activities where required and trained to do so and ensures out of office coverage for PV related matters in LOC.
- Conducts PV training of all local PV employees, non-PV staff, all sites within the territory and where applicable
- Line manage PV resources where appropriate, help organize resources for efficient functioning of the team, track performance of the PV team (where applicable) using the appropriate metrics