PRODUCT SURVEILLANCE ASSOCIATE:

On behalf of our pharmaceutical client, Procom is searching for a Product Surveillance Associate for a 1-year role. This position is an onsite position at our client’s Sturtevant, Wisconsin office.

JOB DESCRIPTION:

We are seeking a Product Surveillance Associates to support clinical and safety assessments of post-marketing events. This role ensures compliance with global regulations and requires interaction with customers, healthcare professionals, and internal stakeholders. The position involves complaint handling, product investigations, technical support, and documentation within the company’s Quality System.

MANDATORY SKILLS:

• Bachelor’s degree in Physical Science, Engineering, or equivalent experience
• Experience in Quality Assurance and/or regulated industry
• Strong technical writing and documentation skills
• Proven problem-solving ability
• Ability to work independently with minimal supervision
• Meets vision assessment requirements (20/20 near vision and acceptable color vision)

NICE-TO-HAVE SKILLS:

• Experience in post-marketing product surveillance
• Familiarity with complaint management systems
• Knowledge of global regulatory requirements in pharmaceuticals or medical devices

• Process field inquiries via phone, email, or verbal correspondence in line with SOPs
• Provide technical support and remote troubleshooting guidance
• Conduct follow-up activities to close records in a timely manner
• Execute product investigations, including product returns, evaluations, and manufacturing record reviews
• Obtain required approvals and ensure compliance with the Company Quality System
• Perform complaint handling and documentation activities within regulatory guidelines