Medical Device Vigilance Associate
4 weeks ago
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.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
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
* Manage the Medical Device Vigilance general email inbox for all MDV studies.
* 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $77,000 to $99,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
#LI-ASR2
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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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