Job Description
Target PR Range: 32-42/hr
*Depending on experience
Job Description:
The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.
Activities performed under this team:
Assisting with ongoing continuous improvement projects spanning across departmental needs
Responsible for individual and periodic medical device safety reporting
Responsible for PI site notifications
Providing support for training and automation efforts
Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.
Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases
Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting)
Clinical Trial Experience
Clinical Trial Device Experience
Knowledge of electronic databases (e.g., Rave EDC, Veeva EDC, Microsoft Office including Excel, Oracle, Veeva, Salesforce Applications and other database tools)
Ability to effectively interact with and influence others without direct reporting relationships
RN Required
Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.
Experience Level = 5-7 Years
*CO/NYC candidates might not be considered
Job Tags
Remote job, Contract work,