Medical Device Vigilance Associate (Hybrid)

Baxter

1-2 years

$77,000 - $99,000 annually

Deerfield

10 May 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Device Vigilance Associate (Hybrid)

Req #: JR - 135826

Location: Deerfield, Illinois, United States

Job Category: GST Operations

Date posted: 05/13/2024

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Company Description: At Baxter, we are deeply connected by our mission to save and sustain lives. With a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, our products and therapies are vital in hospitals, clinics, and homes worldwide. We prioritize employee well-being and recognize the importance of a healthy work-life balance.

Your Role at Baxter:

As a Medical Device Vigilance Associate, your primary responsibility is to support the safety management of post-market products and global clinical trials, focusing on device and combination products. This involves adhering to applicable procedures, guidelines, and regulations.

Responsibilities:

Review SAEs and product complaints/deficiencies data for completeness and clarity.
Initiate and manage SAE/device deficiency reports in the Baxter Device Clinical Trial Safety Database (DCTS).
Format documents for eTMF readiness and manage study document uploads in eTMF.
Maintain and manage the DCTS database alongside the IT team.
Support reconciliation of safety events with the Worldwide Medical Team.
Manage access control and content on the Medical Device Vigilance SharePoint site for clinical studies.
Generate case reports from DCTS and ensure timely submission to applicable functions.
Perform quality checks on all AEs and DDs entered into TW-DCTS.
Own standard operating procedures for DCTS and associated activities.
Support post-market complaint/adverse event case handling as needed.
Perform other duties to support device safety management.

Qualifications:

Bachelor of Science (scientific field preferred).
1-2 years of pharmaceutical and/or device clinical development experience preferred.
Working knowledge of FDA, ICH/GCP, and European Regulatory Authority requirements.
Excellent verbal and written communication skills.
Strong interpersonal and organizational skills.
Ability to multitask with attention to detail.
Proficiency in Microsoft Word, Excel, and Project.
Familiarity with Electronic Data Capture systems such as Medidata Rave preferred.
Working knowledge of safety reporting standards and coding systems preferred.

Estimated Base Salary: $77,000 - $99,000 annually (subject to change based on market data and other factors)

Equal Employment Opportunity: Baxter is an equal opportunity employer, evaluating qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Reasonable Accommodations: Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require accommodation during the application or interview process, please inform us.

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Medical Device Vigilance Associate (Hybrid)

Job Description

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