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Clinical Product Safety Specialist Job in Cleveland, Ohio US

Clinical Product Safety Specialist

Inogen, Inc - Cleveland, OH

Posted: 11/2/2021 - Expires: 1/31/2022

Job ID: 233610202

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Job Description

Clinical Product Safety Specialist

Cleveland, OH, USA
Req #566

Tuesday, November 2, 2021

ABOUT INOGENInogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider. Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.


Job Summary: 


The Clinical Safety Specialist supports clinical event data collections, assessment, adjudication, and analysis. This position also supports internal and external review of safety data by preparing data summaries and presentation.


Responsibilities (Specific tasks, duties, essential functions of the job) 


Process, review, evaluate, and track incoming adverse events.
Interviews appropriate people regarding product complaints relative to the identity, quality, safety, and effectiveness of medical devices.
Assist with upstream and/or downstream processes to obtain additional information regarding AE's.
Assist in the completion and documentation of vigilance cases with timely processing to final closure.
Assists during FDA, ISO, or other third-party audits and implements or assists in implementing corrective and preventive actions.
Maintain regular and punctual attendance.
Comply with all company policies and procedures.
Assist with any other duties as assigned.


Knowledge, Skills, and Abilities 



Strong analytical and signal detection skills

Working knowledge of safety databases

Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills

Demonstrated problem-solving, critical thinking, and investigative skills working relationships

Knowledge of Good Documentation Practices (GDP) as it relates to Product Safety documentation and reporting

Ability to manage confidential information with discretion

High degree of critical thinking skills.

Excellent organizational skills.

Ability to manage diverse and simultaneous projects of various complexity; Ability to solve complex medical safety related challenges.

Strategic thinker able to take on innovative risk while balancing the need to meet timelines.

Strong sense of urgency and a desire to roll up his/her sleeves to do the work.


Qualifications (Experience and Education)


Bachelor's degree in related field, required.
Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience, required.
3+ years of clinical safety experience, required; for Class II Medical Device (respiratory field), preferred.
Intermediate knowledge/proficiency in Microsoft Office, required.
A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

We thank all applicants in advance for their interest in the position. However, only those selected for an interview will be contacted.
Inogen is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legallyprotected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm;http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.The pay transparency policy is available here: https://www.dol.gov/agencies/ofccp/faqs/pay-transparency
Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.netor call (972) 616-5668 and let us know the nature of your request and your contact information.

Other details

Job Function
Individual Contributor

Pay Type
Hourly

Required Education
Bachelor's Degree

Cleveland, OH, USA

Share this job:

Inogen is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm ; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf . The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf .

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
61005651
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A