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Product Monitoring Specialist

Date:  Jan 14, 2022
Location: 

Maryland Heights, MO, United States

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

 

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

 

Summary of Position

The Product Monitoring Specialist is primarily responsible for monitoring the safety, quality, and efficacy of all products marketed and sold by Curium in North America by receiving, capturing and evaluating product feedback reports from the field in accordance with current FDA and Health Canada regulations and guidances.  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 analyses 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.
  • 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, Power Point, 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.

 

Working Conditions:

  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Willingness to work in a team based environment.
  • Close attention to detail required.
  • May be required to sit or stand for long periods of time while performing duties.
  • Must be able to work outside of regular work hours. 
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation. 
  • Must possess good hand-eye coordination.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

 

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 


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