Sr Post Market Surveillance Specialist

PURPOSE AND SCOPE:

Receives, reviews, processes, and analyzes all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy.

Helps provide high level customer support and serves as a liaison and subject matter expert between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints.

Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends.

Responds to questions and liaises with fellow department staff members regarding complaint data entry and processing.

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* A seasoned, experienced professional with a full understanding of complaint handling/post market surveillance, resolves a wide range of issues in creative ways.


* Ensures complaints are processed in a uniform and timely manner, whether they are equipment, drug, or device origin and those oral complaints are documented upon receipt using good documentation practices (GDP).


* Responsible for receiving, reviewing entering, evaluating data into the Compliant Management Database regarding customer/patient product inquiries and complaints and further processing complaint files.


* Interfaces with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples.


* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions.


* Networks with senior internal and external personnel in own area of expertise.  


* Normally receives little instruction on day-to-day work, general instructions on new assignments.


* Provides training during orientation and on-boarding of new staff.  Mentors staff members regarding complaint processing.  Acts as a resource for department staff members on complex complaints.


* Applies knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process within regulatory timeframes.


* Processes MDR/ADE decision trees and is able to complete MDR submissions.


* Understands the Field Alert Reporting (FAR) process and evaluate, distinguish, and recommend complaints for FAR reporting.


* Understands complaint data analysis and is able to present complaint trends to management.


* Provides coding support and reviews and updates complaints in the Compliant Management Database


* Determines product and incident complaint codes and responds to questions regarding complaint coding from staff members. 


* Assigns complaint class based on the master symptom code severi...