Clinical Safety Specialist

Work Shift:

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.

ESSENTIAL FUNCTIONS PERFORMED

1. 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.
2. Assists in ensuring all adverse event information is logged and tracked from initiation to closure for assigned projects.
3. Collaborate with Project Manager and Data Manager on Safety Oversight for assigned projects.
4. 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.
5. 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.
6. 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.
7. 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.
8. Contributes to safety narrative writing.
9. Ensure reconciliation between safety information and other departments as required.
10. Attend safety meetings with internal and external stakeholders regarding Safety profile for assigned clinical trial projects.
11. Attend audits and inspections, as required.
12. Performs other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs. - local practice may apply.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

* 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%.

COMPETENCIES

* Clinical safety knowledge/experience
* Computer skills
* Analytical skills

COMMENTS

Infectious Control Risk Category I:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure.

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* Low Cost Onsite Medical Clinic

* Two (2) Onsite Cafeterias

* Employee Garden | Gardening Classes

* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

* 401K | Health Savings Account

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Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.