Senior Medical Events Specialist
Where
- Santa Ana, CA
What you'll be doing
- Ensures compliance to medical event reporting regulations worldwide by supporting and directing improvements to the medical event procedures and processes. Facilitates process improvement related to medical event reporting. Evaluates and monitors medical event metrics and presents medical event data at monthly and quarterly meetings. Provides analysis and summary of safety data as needed for submission to country authorities. Responsible for the timely review; documentation and filing of medical event reports and international vigilance reports for global AMO medical devices as needed. Provides support during internal and external inspections (e.g. FDA; TUV; AQR; etc.) for the medical event reporting process. Responsible for compliance with applicable corporate and divisional policies and procedures. Provides operational leadership support to the medical events group. Serves as a department lead on cross-functional teams or divisional projects in the development of procedures and processes related to medical event reporting. Generates medical event management review metrics, conducts analysis and uses data to help identify areas for process improvement. Acts as the medial event representative for the risk management process, including evaluation of on-market product issues and identification of appropriate actions to mitigate risk. Provides subject matter expertise, leadership, and training as appropriate to other medical event analysts and to those outside of the MEG that impact the medical event reporting process. Ensures timely filing of reportable events with regulatory agencies worldwide.
What your background should be
- Minimum of five (5) years experience working in medical complaint handling with medical devices or pharmaceutical products. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), keyboard use (greater or equal to 50% of the workday). Clinically/medically trained professional with knowledge of FDA/international guidelines for medical device safety reporting requirements preferred.
Required Schooling / Training
- BA/BS in technical/scientific discipline is required.
Who is the client company
- The client company is a healthcare service provider.
- If you are interested in this position, send your resume to apply@kochdavis.com
