Clinical Safety Specialist

Merit Medical Systems, Inc.

About The Position

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Requirements

Education and/or experience equivalent to a bachelor's degree in a biological science or relevant discipline and two years of clinical safety management experience.
Has working knowledge and familiarity with US Federal Food and Drug Administration and ICH/GCP.
Excellent written/verbal communication and organizational skills; ability to work as a team player.
Self-motivated, self-directing, strong attention to detail and excellent time management skills.
Strong analytical skills.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Ability to travel up to 10%.

Responsibilities

Monitor/oversight of all adverse events, serious adverse events (SAEs), major adverse events (MAE) and product complaints / deficiencies occurring in pre-and post-approval clinical studies globally.
Assists in ensuring all adverse event information is logged and tracked from initiation to closure for assigned projects.
Collaborate with Project Manager and Data Manager on Safety Oversight for assigned projects.
Assist in developing and reviewing Safety Management plans for assigned projects, including but not limited to, Clinical Events Committee Charters, Data Safety Monitoring Board Charters, Medical Monitor safety plans, safety adjudication Case Report Forms, etc. in accordance with Protocol, applicable SOPs and regulatory requirements.
Assist in composing general safety narratives and process clinical trial serious adverse events (SAE) and/or major adverse events (MAE) reports within required timeframes as needed and as applicable.
Collect the clinical study data and source documentation for the adjudication of events, prepare narratives for each event as well as final packets to provide to adjudicator as specified by each individual project charter.
Review all alert emails for reported events for each study. Distribute a follow up email for each reported event to include any additional pertinent information regarding the reported event.
Contributes to safety narrative writing.
Ensure reconciliation between safety information and other departments as required.
Attend safety meetings with internal and external stakeholders regarding Safety profile for assigned clinical trial projects.
Attend audits and inspections, as required.
Performs other duties and tasks, as required.