Senior Clinical Safety Specialist

Advantage Technical; Minnetonka (MN); Remote; Full time

Job summary

A leading company in the medical device industry is seeking a Safety Specialist to manage safety deliverables and ensure compliance with quality standards. This role involves overseeing adverse event processing and authoring safety plans, requiring a strong background in clinical trials and medical devices. The position offers a competitive hourly wage and the flexibility of remote work with occasional travel to Minnetonka.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum 5 years clinical trial experience within role of safety required.
• Must have 5 years in a Medical Device setting.

Responsibilities

• Manage adverse event processing including report review and expedited reporting.
• Author study specific safety documents and plans.
• Conduct Clinical Trial Safety Review meetings.

Skills

Clinical Trial Safety

Safety Management

Quality Compliance

Education

Bachelor's degree in science-related field

Tools

BS database

Job description

2 days ago Be among the first 25 applicants

This range is provided by Advantage Technical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$52.00/hr - $59.00/hr

Direct message the job poster from Advantage Technical

Shift: Monday through Friday from 6 am till 2:30 pm

Remote work but may have to travel to Minnetonka, Minnesota on occasion

Must have 5 years in a Medical Device setting

• Manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division.
• Responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.
• Manage adverse event processing including report review, safety query management, and expedited reporting
• Assess type/level of processing to be done for adverse events
• Author study specific safety documents and plans (e.g.: safety plan, CEC/IMR Charter, etc.)
• Acting member of clinical core team
• Conduct Clinical Trial Safety Review meetings
• Ensure adjudication and reconciliation of safety events are completed prior to data snapshots
• Provide safety-related input to other study documents/processes as requested (e.g.: protocol, CRF design, etc.)
• Manage functional deliverables to ensure study milestones are not delayed
• Management of additional projects, deliverables, and timelines to support additional activities within the clinical department
• Quality System Responsibilities: In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Will use the BS database

Required qualifications:

• Minimum bachelors degree or equivalent experience in science-related field
• Minimum 5 years clinical trial experience within role of safety required
• Must have 5 years in a Medical Device setting
• Proven or prior experience with clinical trial safety

Preferred qualifications

• Therapeutic knowledge in Urology Knowledge of GCP Experience with processing and assessing safety events and medical narrative writing
• Clinical database and systems experience

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Advantage Technical by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Safety Specialist” roles.

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.