Product Complaint Specialist
Proclinical is currently recruiting for a Product Complaint Specialist with a biopharmaceutical company located in North Chicago, IL.
- Responsible for the receipt, processing, triage and quality assessment of all inbound safety information including adverse events and technical complaints for the company's marketed products (drugs and devices).
- Ensure compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety information.
Skills and Requirements:
- A bachelor's degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
- 0-3 years' work experience in a cGMP related industry or in a clinical setting is preferred.
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.