Post Market Clinical Reporting Specialist - temp 12 months

☞ Intuitive

Visualizza: 259

Giorno di aggiornamento: 26-03-2024

Località: Aubonne Vaud VD

Categoria: Garanzia di qualità / Controllo di qualità

Industria: Medical Devices Computer Software Hospital & Health Care

Posizione: Entry level

Tipo di lavoro: Full-time

Loading ...

Contenuto del lavoro

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.
Skills, Experience, Education, & Training
  • 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.
Shift : Shift 1 - Day

Travel : No

213005
Loading ...
Loading ...

Scadenza: 10-05-2024

Clicca per candidarti per un candidato gratuito

Applicare

Segnala lavoro
Loading ...
Loading ...

LAVORI SIMILI

Loading ...
Loading ...