Technovigilance Specialist
Location
Barueri, SP | Brazil
Job description
Job Description
Primary Function of Position
The Technovigilance Specialist is responsible to investigates customer complaints that are registered by Intuitive Brazil, makes reporting decisions, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation. The Technovigilance Specialist needs to ensure that all events applicable to an assessment from Brazil (National or Worldwide) will be done according to the current ANVISA requirements and company procedures.
Essential Job Duties
This position has responsibility and authority for:
Investigating complaints daily:
- Perform the classification of complaints and escalate complaints that require additional review for Brazil complaints (National or Worldwide).
- Evaluate Brazil complaints for reportability to determine whether the complaint falls within the category of a reportable event to the Ministry of Health (ANVISA) in accordance with Brazilian regulatory requirements.
- Document the decision-making rationale with the completed decision tree.
- Submit initial and supplemental regulatory reports, as applicable, to the Ministry of Health (ANVISA) per regulatory requirements.
- Document acknowledgements of regulatory reports successfully received by the regulatory authority.
- Archive all notification files properly, according to the type of the event.
- Interface with the distributor to gather additional information to conclude the ANVISA reports as:
- Traceability of the Affected Items.
- Data about the Failure Analysis (FA) Letter delivered to the customer.
- Close all complaints properly.
- Assess and review all new information for Brazil complaints after the complaint is closed for potential change of reportability. l
- Monitor the Brazilian requirements and notify Intuitive RSM when changes to the Brazil regulation impact the complaint and regulatory reporting process.
- Provide peer review and feedback of complaints and reports.
- Participate in new hire training and continuous Regulatory Compliance training as required.
- Participate in process improvement activities to continuously improve process effectiveness.
- Works closely with Corporate Post Market team.
- Execute on projects as required.
- Perform other duties as directed.
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Job tags
Salary
