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Assoc MDR/Vigilance Spec

Lafayette, CO 80026

Posted: 09/13/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 585655 Is job remote?: No Country: United States

Job Description


 Please provide a brief description of what the role entails
  • Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
  • Writes investigation summaries based on technical product analysis information provided
  • Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
  • Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety, and effectiveness of medical devices.
  • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

Top 3 technical  skills that you are looking for in a candidates experience:
  1. Medical device industry experience
  2. Technical writing skill
  3. Excellent communication skills (oral and written), with strong organizational and analytical skills

 

Education Required: Bachelor’s degree required

Years’ Experience Required: 0+ years of experience

 

Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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