**Primary Job** **Function:** + To provide support in the establishment, maintenance and development of the PV compliance monitoring system. + Review and data entry of metrics in compliance tracking systems and tools. + Metric collection and preparation of the regular management reports **Core** **Job** **Responsibilities:** • Collection of compliance data within GPV and other stakeholders of the PV- and medical device vigilance system within the agreed timelines. • Maintains and further develops the compliance monitoring system and compliance tracking databases with the support of IT. • Collates metrics and drafts compliance overviews (Key Performance Indicators (KPls), PV Compliance Summaries). • Requests non-compliance information _I_ corrective/preventive actions when not provided by the non-compliant party. • Performs regular CAPA reviews and follow-up with responsible organization in case of quality issues • Manages the tracking of non-compliance information/ corrective/preventive actions and generates periodic reviews of compliance data and trending of root causes. • Initiates investigations of non-compliance occurrences and documents investigation findings and proposes solutions according to the process defined within GPV. • Assists in the liaison with relevant interfaces to ensure compliance is monitored for GPV through relevant KPls. • Participates in training of relevant personnel on Compliance relevant topics (e.g. Affiliate tracking of submissions, CAPA Management Tool). • Escalates to the Head PV System & Compliance, and if applicable the QPPV, any serious compliance or performance issues in order to take immediate action (corrective - or preventative action). An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com