PV Monitoring and Compliance • Accountable for ensuring compliance with local and regional PV regulations and company’s policies/procedures and take corrective and/or preventive actions, when needed • Ensures the timely implementation of new or revised PV-related regulatory requirements across AAP region, and provides the appropriate briefing or training on any changes to the regulations. • Collaborate with the Regional PV office for process improvement initiatives and corrective and preventive actions identified by the Regional PV office • Liaise with the Global PV Alliance Management for the development of Safety Data Exchange Agreements (SDEAs)/ PVAs impacting the country/region • Develop and implement monitoring programs to ensure regulatory requirements for PV requirements are complied with and risks are minimized. • Develop and implement in yearly PV self-assessments, assist with PV audits/inspections at the affiliate and assist in developing CAPAs in response to findings/observations with guidance from CQM (Clinical Quality Management) • Liaise with the MAH including Affiliates and other business units to keep them appraised of safety activities and to provide input on strategic decisions and to ensure that activities performed by those functions adequately address PV requirements