POSITION SUMMARY:
The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex...
and key partners, maintaining alignment with global standards and Italy regulatory expectations.
• Oversee location strategy and event approvals for brand activations across Italy.
• Partner closely with Legal and Policy to ensure full compliance with...
adequately trained in identifying and reporting AEs/SAEs
• Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner
• Performs drug accountability...
reduction' compliance' and reporting obligations. - Foster knowledge sharing and collaboration with VF teams in other regions to drive best practise adoption globally to prepare for emerging regulatory compliance. - Represent the Global Sustainability team...
to-date knowledge of international reporting and regulatory regulations to ensure compliance.
• Proficiency with key IT systems and databases relevant to pharmacovigilance (e.g., EudraVigilance).
• Good working knowledge of common office software...