Medical Device Vigilance Associate

2 weeks ago

Deerfield, United States BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

**Your Role at Baxter**:
The primary responsibility is to support the safety management of post market products and global clinical trials with a focus on device and combination products in accordance with applicable Baxter Global Clinical Development procedures, Global Field Surveillance (GFS) procedures, Global Patient Safety (GPS) procedures, ICH GCP Guidelines, and applicable local regulations.

**What you'll be doing**:

- For device studies, receive SAEs and product complaints/deficiencies data, review for completeness or need for clarification in collaboration with the Medical Device Vigilance Clinical Safety Manager and initiate queries as necessary.
- Initiate and, if applicable, manage SAE/device deficiency reports in the Baxter Device Clinical Trial Safety Database (DCTS).
- Format documents for eTMF readiness. Upload, edit and approve study documents in eTMF as applicable.
- Manage DCTS database alongside IT team and perform database process owner role.
- Support reconciliation of safety events with Worldwide Medical Team.
- Access control and content management of the Medical Device Vigilance SharePoint site for clinical studies.
- Generate case reports from DCTS and manage submission of case reports to applicable functions to meet reporting timelines globally.
- Quality Check all AEs and DDs entered into TW-DCTS
- Standard operating procedure ownership for DCTS and associated activities.
- Support post-market complaint/adverse event case handling when needed
- Perform other duties needed to support device safety management.

**What you'll bring**:

- Bachelor of Science (scientific field preferred)
- 1-2 years pharmaceutical and/or device clinical development experience preferred.
- Working knowledge and familiarity with US Food & Drug Administration, ICH/GCP, and European Regulatory Authority requirements as applicable to clinical trials.
- Excellent verbal and written communication skills required.
- Interpersonal and organizational skills required.
- Ability to multitask with a strong attention to detail.
- Working knowledge of common office and scientific computer programs such as Microsoft Word, Excel and Project.
- Familiarity of Electronic Data Capture systems such as Medidata Rave preferred.
- Working knowledge of safety reporting standards and MedDRA and WHO coding preferred.

LI-ASR2

**Equal Employment Opportunity**

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

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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