Product Complaint Specialist job in North Chicago, USA

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Phone Number*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Product Complaint Specialist with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

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.

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