This position serves as a hybrid role to be a subject matter expert in managing drug safety case information, as well as supporting device safety complaints within the Global Complaint Management (GCM) organization. This includes: daily monitoring of the Drug Safety mailbox with triage and forward of new case data, maintenance of the drug case tracker, tracking on-time regulatory reporting, communicating with vendors performing safety activities on behalf of ICU Medical, reviewing cases in ICU Medical workflow, supporting aggregate reporting activities for drugs, interfacing with regional partners to maintain current knowledge in device regulatory requirements for device post market surveillance, managing high risk complaints involving customer advocacy issue, death or serious injury, facilitating Medical Assessments for device complaints, assisting with new employee training, and participating in site audits as needed.
Essential Duties & Responsibilities
Serve as a subject matter expert for drug/solution and device safety complaints within the Global Complaint Management (GCM) organization.
Provide guidance to Analysts within the Global Complaint Management (GCM) organization
Maintain current knowledge in regulatory requirements for drug/solution and device complaints and adverse event reporting globally to ensure compliance.
Track and ensure on-time regulatory submissions for drug/solution and device complaints to FDA and global regulatory agencies.
Responsible for escalating late report submissions, and ensure necessary investigations are initiated.
Maintain case tracker and Drug Safety Mailbox with triage and forward of reports as received each day.
Maintain pertinent communication with vendors performing drug safety case processing including maintenance of database, reconciliation activities, and day to day input and feedback as needed.
Manage high risk complaints involving customer advocacy issues, death or serious injury, as well as facilitate Medical Assessments for device complaints.
QC cases in Safety Database upon appearance in ICU Medical workflow.
Complete periodic/aggregate reports as assigned.
Assist with new employee training.
Maintain working knowledge of complaint processing to be able to serve in back up capacity.
Provide support for audits and work on special projects as they arise.
May serve as operations team leader in the absence of the team manager.
Works independently and is accountable for completing task as assigned. Works well in a team to accomplish team goals.
Work on special projects as they arise.
Knowledge, Skills & Qualifications
Experience with or knowledge of medical terminology and how the drug and device products are typically used in a clinical setting.
Intermediate experience with computers and software such as Outlook, Word, Excel, PowerPoint, WebEx, TrackWise.
Must be able to communicate effectively with internal and external customers.
Must demonstrate critical thinking and problem-solving skills.
Proficiency in complaint data analysis and MDR/Vigilance data analysis and presenting a summary to management.
Education and Experience
Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science, or other scientific field.
Minimum 5 years of experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business.
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
Physical Requirements and Work Environment
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.