Position Description

Summary of Position

The Product Monitoring Specialist is primarily responsible for monitoring the safety, quality, and efficacy of all products marketed and sold by our North American client by receiving, capturing, and evaluating product feedback reports from the field and in accordance with current FDA and Health Canada regulations and guidance’s. Additionally, they provide technical and clinical information regarding product usage and performance. As a result of these activities, they will work to insure patient safety. Additionally, they will develop, preserve, and strengthen customer (internal and external) relationships.

Essential Functions

• Capture, review and analyze product complaints
• Follow up on customer usage reports and field service reports as necessary
• Comply with relevant North American product and device quality related guidelines, standards and regulations regarding the receipt, review, investigation and reporting of product usage experiences. It also includes evaluation of complaints for possible Adverse Events which are then forwarded to pharmacovigilance for review.
• Collaborate with field service and manufacturing site personnel
• Conduct trend analysis in order to provide an alert to changing safety profiles on regular and ad-hoc basis
• Prepare and deliver accurate reports of continuing product performance for use within and outside of the department
• Identify potential product performance issues and alert appropriate management personnel when needed
• Provide oversight of customer usage experiences, product safety reporting, and professional consultation in matters related to safety and proper product functioning
• Work in conjunction and effectively communicate with various departments, including Regulatory Affairs, R&D, Marketing, Sales and Customer Service
• Provide clinical, technical support, and trend analysis of marketed products and devices
• Provide product performance expertise on cross-functional project teams as necessary
• Participate in Health Hazard Evaluation process which may include initiation and coordination of a HHE (Health Hazard Evaluation)
• Participate in field actions/recalls involving marketed products and devices
• Expanding technical and clinical knowledge of current and new marketed products and devices
• Provide support during audits and regulatory inspections
• Be responsible for and ensuring corrective action and preventative action plans are complete from product monitoring complaints
• Assisting with annual product reports

Requirements

• BA/BS Degree in life science, engineering, or equivalent. Nuclear medicine technologist, nurse, pharmacist, pharmacy technician or other healthcare training preferred
• Five years of clinical / practical experience in a relevant clinical environment
• Previous Regulatory Affairs, Quality Assurance experience in the pharmaceutical and/or medical device industry is strongly preferred
• Involvement with Health Hazard Evaluations or similar equivalent
• Knowledge of the clinical area, including products, procedures, and scientific and medical literature
• Experience interacting with regulatory agencies such as the FDA
• Writing skills necessary to effectively communicate technical/clinical information to others
• Comfortable and capable of expertly using software programs (Word/Excel/PowerPoint/Outlook) and a willingness to expand and increase these competencies.
• Superior verbal communication skills including impeccable telephone etiquette and questioning skills
• Scientific literature evaluations skills are preferred
• Involvement with field actions for drugs and/or medical devices
• Problem solving and analytical skills
• An ability to effectively integrate customer and business needs in a satisfactory manner
• Sound organizational skills with the ability to prioritize tasks
• Ability to build productive relationships with personnel within and outside of the department and company
• Ability to work effectively in multi-functional teams

Job Type: Contract

Pay: $32.55 - $36.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance
• Work from home

Experience level:

• 5 years

Shift:

• Day shift

Weekly day range:

• Monday to Friday

Work setting:

• Hybrid work

Work Location: Hybrid remote in Maryland Heights, MO 63043