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Post Market Clinical Reporting Specialist - temp 12 months
View: 261
Update day: 26-03-2024
Category: Quality Assurance / Quality Control
Industry: Medical Devices Computer Software Hospital & Health Care
Position: Entry level
Job type: Full-time
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Job content
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.Primary Function Of Position
Responsible for day-to-day case management of serious adverse event (SAE) records (adverse events and side effects/reactions), and regulatory reporting following incidents escalated by Health Care Practitioners during post-market Clinical studies performed on European markets by or on behalf of Intuitive Surgical.
This position will assess incoming communication to identify potential SAE reports, and follow-up with the associated sites for additional information. This role is responsible for handling adverse event accountabilities in order to comply with local and international regulations, guidelines and applicable directives.
Roles & Responsibilities
- Record all Adverse and Serious Adverse Events notified by Intuitive Surgical Clinical Affairs point of contact.
- Liaise with the Clinical Affairs team to ensure that clinical documentation/ processes meet are in line with actual standards and regulations per post-market expectations.
- Contacting sites to obtain key relevant data for case management.
- Prepare and submit SAE reports to the proper regulatory authority within the required reporting period.
- Notify Adverse and Serious Adverse Events as appropriate to European and Swiss Authorized Representatives.
- Provide support for internal audits and external inspections related to SAE reporting.
- Identify and escalate any issues identified before they become critical.
- Define with internal stakeholders metrics demonstrating compliance and performance of the activity.
- Other regulatory tasks and projects may be assigned as necessary.
- Swiss CFC or Bachelor’s degree in Biomedical Engineering, Life Science (or equivalent).
- 0.5 to 2 years of experience in clinical trials (pre-market or post-market). Preferably for medical devices.
- Basic understanding of documentary and SAE reporting requirements for clinical studies under EU Medical Device Regulation (MDR) (2017/745/EU).
- Fluent (C1 minimum) in written and spoken English (business language used). Preferred: French and/or German at B2 level. General computer literacy (Microsoft Office, etc.)
- Preferred: Working knowledge of medical terminology, medical conditions, and biological systems.
Travel : No
213005
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Deadline: 10-05-2024
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