Adverse Events Reporting/PRODUCT COMPLAINT Specialist

 I. Position Summary

 In compliance with current Good Manufacturing Practices (cGMPs), departmental SOPs and corporate policies, the Product Complaint Specialist is responsible for ensuring prompt, thorough and consistent investigations of product quality complaint allegations across all manufacturing sites for the client's Rx products and products within the scope of the Product Quality Complaints (PQC) Group and keeping site and client's management informed of complaint related trends/ quality concerns.

 II. Essential Functions
Performs the following functions independently:

·Reviews the documentation and investigation of all quality related complaints concerning prescription drug products and medical devices

·  Insure timely and proper investigation of complaint issues and returned complaint samples, as required.

·  Prepares the necessary responses to complainants outlining the results of investigations.

·  Monitors complaint data and prepares reports

·  Notifies management of situations that may require regulatory reporting and/or potential product recall.

·  Maintains and updates computer database and hard copy files (where necessary) for tracking of complaints.

·  arranges product/batch investigations of adverse events and/or medical device malfunctions.





VII. Education

·  Bachelor of Science or advanced degree in a scientific or medical discipline

 

VIII.  Experience

·  Five or more years of experience in Quality Assurance, manufacturing, product development, clinical, non-clinical or other scientific discipline.

·  Knowledge of techniques, practices, precedents, theory and principles of Quality Assurance or pharmaceutical development.

· Previous experience with product quality issues or adverse event reporting is a MUST.

·  Previous experience dealing with healthcare professionals and/or consumers is beneficial

 

Please respond with JOB# LNE-Adverse in the subject of your email.