Clinical Safety Specialist II job – St. Jude Medical – Plymouth, MN

Clinical Safety Specialist II

St. Jude Medical

233 reviews

Plymouth, MN

We are seeking an experienced, high caliber Clinical Safety Specialist II. We are seeking an experienced, high caliber Clinical Safety Specialist II. The Safety Specialist II will work under the direction of the Safety Manager, Global Clinical Operations processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects.

Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on St. Jude Medical:

  • Processes all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting
  • Collaborates with Safety team members in preparation for DMC/DSMB/CEC meetings
  • Oversees weekly review of adverse events with applicable study teams. Reviews all adverse events in accordance with the specified Clinical Investigation Plan (CIP)
  • Codes adverse events where directed by the governing processes. Drafts AE narratives, as required, for inclusion in all FDA report submissions
  • Works with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events
  • Maintains knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products
  • Assists with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting
  • Assists with revision or writing of SOP/Instructions/Procedures and changes to support clinical department
  • Assists in development of study specific case report forms
  • Assists in clinical study protocol development
  • Assists with BIMO audits, when directed. Collaborates on additional Clinical Research activities

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • Bachelor’s degree in an area of science or RN
  • Strong understanding of adverse events and risk assessment
  • One of the following:

    • 2-3 years’ experience within pharmacovigilance or medical device safety;
    • 3+ years’ experience in medical device or Pharma in clinical research or risk assessment
  • Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards
  • Proficient in MS Office and database navigation skills
  • Strong interpersonal and communication skills
  • Excellent record keeping, organizational skills, and problem solving abilities
  • Highly motivated and capable of working independently and as a team member
  • Experience coordinating, prioritizing, and setting timelines for multiple tasks
  • Ability to multi-task and adapt to a rapid pace environment
  • Strong technical writing skills

Your preferred qualifications and education:

  • 2-3 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena
  • Master’s degree or MD

233 reviews

St. Jude Medical is now Abbott.

St. Jude Medical was founded in St. Paul, Minnesota in 1976 with the mission of further developing…

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