Responsibilities

Communicates verbally and in writing both internally and externally with client regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file Collaborating with local Complaint intake teams to verify or request additional information to help evaluate complaint.

Collaboration within the team, peers and managers to provide update and share information. Participate and lead activities assigned by Manager and update internal and external stakeholders. Participate in client and team internal meetings / Conference calls as needed Activity: Investigates complaints/events in a timely manner.

Maintains accurate entry of complaints in database. Independently assesses the complaint to determine next steps and follows QMS process as agreed with client.

Ensuring completeness of complaint records through Vigilance due diligence tasks Ensuring completeness of records due to wrong/missing information due diligence tasks Initiating continuous improvement activities Monitoring source (data entry) system updates Assisting Global Complaints

Handling Management in the successful identification and resolution of quality issues associated with complaints Maintaining quality records to ensure compliance with global clients requirements Serve as a backup for the Global Vigilance team to support high volume spikes Determine the severity of the problem and next actions.

Entering info from the service report into the digital tool (ERP) - ETQ Make a decision and complete evaluation by classifying the issue into a tier.

Explain complaint files during audit situations.

Reviews files for closure and completeness. Determination if investigation is required (Tier determination) Final evaluation & closure of complaints Translate any document required from Spanish to English or English to Spanish Work any other activity related to an inquiry or complaint as part of the end to end cycle of the transaction or the end to end process