ZOLL

Safety Director

ID 2021-1971
Job Locations
US-MN-Minnetonka
Job Post Information* : Posted Date
1 month ago(9/22/2021 1:13 AM)
Category
Clinical
Job Post Information* : External Company URL
https://careers-zoll.icims.com/jobs/search

Company Name

ZOLL Respicardia

Overview

The Safety Director at ZOLL | Respicardia leverages patient facing clinical experience and training to lead and/or participate in safety signal detection activities to allow signal identification, evaluation, validation, and management for marketed products including individual and aggregate data analyses, interpretation of safety signals and trends, documentation, and communication of safety risks in collaboration with key internal and external stakeholders. Uses professional background from prior work in clinical setting to understand context of medical devices on potential risks and benefits to patient (medical) safety. Participates in the strategic planning, management, and execution of activities related to the safety and performance of investigational products that are in the early, clinical development, and post-market stages of commercially approved device systems. Functions as medical reviewer for clinical trials and provides clinical insight during product development, clinical trial design, and life cycle management activities.

 

This full-time position reports to the Chief Medical Officer at our Minnetonka, MN facility.

Responsibilities

Primary Responsibilities:

  • Performs professional medical evaluations of medical device performance, clinical data from complaints, and impact on medical safety of products in development.
  • Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal surveillance, detection, and processing.
  • Reviews, contributes, and approves risk and/or benefit-risk assessments (i.e., health hazard evaluations) for marketed products, including hazardous materials in support of materials compliance.
  • Authors safety assessments for multiple purposes and provides medical oversight / approval for any concern impacting potential safety of patients / donors.
  • Reviews, contributes, and approves risk management plans and reports on behalf of medical safety.
  • Contributes to relevant safety, risk management, and risk-benefit sections of clinical study documents (ie, Clinical investigation plan, Investigator’s brochure).

Additional Responsibilities:

  • Participates in clinical development plan for products to ensure clinical input and appropriate medical safety oversight.
  • Reviews and contributes to the development of relevant clinical study documents (i.e., Informed consent form), clinical study reports, and manuscripts.
  • Reviews and contributes to clinical risk documents.
  • Collaborates with cross-functional product development teams on risk minimization activities and plans.
  • Participates in and contributes to relevant field action/ recall activities.
  • Provides medical reviews of observations/complaints/AEs/SAEs to determine device and/or study relatedness and expectedness.
  • Position reports directly to the Chief Medical Officer.
  • Travel expected 5-10% of time, as needed.

Qualifications

 

Education:

  • Healthcare Clinical Background (MD, RN, CNS, NP, PA, or equivalent).
  • Preferred: Training in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, Medical Quality.
  • At least 3 years clinical/hospital experience following completion of postgraduate training.
  • At least 2 years clinical research / academic experience.
  • Preferred: 2 years pharma/biotech/medical device experience in a medical safety role.
  • Preferred: Experience in sleep medicine or cardiology.

Skills:

  • Knowledge and understanding of the global processes, regulations, and reporting requirements for medical device- and/or pharmaco-vigilance and risk management and minimization activities including:
    • Signal detection, evaluation, and management.
    • Aggregate data analysis, interpretation, and synthesis.
    • Ability to critically appraise literature and perform literature search, evaluation, and assessment, as needed.
    • Ability to apply medical concepts and terminology to clinical and non-clinical settings.
    • Ability to analyze various datasets, interpret results, and convey complex scientific data in a clear, concise, and understandable manner to a scientific as well as non-scientific audience.

You take care of Zoll | Respicardia and we'll take care of you!

 

ZOLL provides:

  • A casual work environment.
  • Competitive salaries.
  • A compensation structure that rewards contribution and hard work.

Benefits include:

  • 401(k)
  • Medical
  • Dental
  • Vision
  • Life
  • AD&D
  • FSA
  • STD/LTD
  • Paid Time Off
  • Tuition assistance

You are qualified, interested and want to apply!

 

Please visit us at:

 

Current Job Opportunities at ZOLL - Careers At Zoll - ZOLL Medical

 

ZOLL appreciates and values diversity. We are an equal opportunity employer and do not discriminate in hiring or employment on the basis of race, color, religion, national origin, citizenship, gender, gender identity, genetic information, marital status, sexual orientation, age, disability, veteran status, or any other characteristic protected by federal, state, or local law.

 

ADA: ZOLL will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

 

https://www.respicardia.com/about/careers/

remede.zoll.com

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed