PV Compliance Specialist

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
  
  

• 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