Medical Reviewer Safety Reviewer

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 PSQ 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.
• Responsibilities include medical review and assessments, which involve in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May collaborate with regional contract CRAs, and organize the files associated with several clinical studies.
• Provides medical support which may include Adverse Event Reporting - the investigation and reporting of medical devices products, in depth investigation of medical device adverse events and collaboration with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on medical device adverse events for the health authorities.
• May provide training internally on safety issues, responsible for serious adverse events processing and reporting.
• 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
• Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
  
  

Qualifications

• Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
• RN Required (Active licensure)
• CRO experience
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints, SADE potential and IVD 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
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
• Ability to Meet Challenging Milestones with results orientation - Skilled
• Strategic Decision Making and Negotiation - Skilled
• Facilitating Change and managing conflicts - Skilled
• Ability to Problem Solve Independently & with Others - Highly Skilled
• Business Organization & Industry Awareness - Highly Skilled
• Cross Functional Relationships and communication skills - Highly Skilled
• Execution / Results / Process Improvement - Highly Skilled
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.