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A. Primary function

Responsible for managing a GCM event through its entire life-cycle, from initial trial referral through regulatory reporting, sample retrieval, investigation, and ultimately to closure/reopening as needed. Analyst is also responsible for knowing when an event is sufficiently complex with significant consequences to escalate the event.

B. Major duties and responsibilities 

1. Primary, single source customer contact

2. Responsible for gathering event registration information (as defined by SOPs) for customers

3. Owns and manages the event through life-cycle from registration through regulatory reporting, sample retrieval, investigation, and ultimately to closure/reopening as needed

4. Responsible for contacting SMEs and GCM Support roles as needed to obtain complaint closure - need to know when to escalate events for reassignment to GCM Specialist

5. Responsible for creating the draft regulatory report for review by the GCM Regulatory Reporting and/or Risk Management roles

C. Educational background

Preferred - 2 or 3 year diploma/certificate in Nursing, Bio-Medical Engineering; Pharmacy Technical

D. Experience

Any of these would provide necessary experience:

• Two to three years of experience working in a health care environment
• Two to three years within a bio-medical engineering discipline
• Two to three years within a quality/compliance organization in an FDA regulated business, preferably in a function required to provide regulatory reports regarding product quality

E. Problem solving

Perform analysis in order to determine the general cause of issues utilizing information obtained in the course of testing, investigation, and communications, appropriate for situations with potential regulatory risk

F. Accountability

Required to make regulatory reporting decision, know when to escalate issues, assume ownership of complaint to receipt to closure, and to make independent decisions and take appropriate action

G. Analytical Ability

Full ownership of given complains requires high level of analytical ability in understanding nature of the complaint as well as its technical aspects, identification of primary issues, developing a plan of action, what resources are required for resolution, and what is required for closure of the event

H. Authority to act

Authority to make decisions, to proceed, quickly on assessments, to identify level of reporting requirements, to escalate events to the next level of authority and to bring closure to an event