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Summary:

This position is a member of the Safety Submissions team within Global Pharmacovigilance and is responsible for electronic distribution and submission of individual case safety reports (ICSRs). This includes maintaining and setting up electronic submission rules in the pharmacovigilance database.

Essential Duties and Responsibilities:

Create and issue regulatory reports, including individual case safety reports.
Run and/or monitor electronic submissions of ICSRs to Regulatory Authorities, affiliates, or business partners as appropriate
Participate in peer review of submissions performed by another member of the team.
Support set up and maintenance of electronic submission rules and reportability by product and recipient in the pharmacovigilance database to ensure electronic reporting is performed in compliance with applicable regulations and guidelines.
Assist in providing electronic submission intelligence to Safety Operations in order to facilitate proper coding of AE data. This covers ICH E2B and HL7 data standards as well as future developments in that area. For ease of reference, they are all referred to as E2B in this document.
Assist Safety Operations in troubleshooting E2B rejections in order to make the necessary corrections to get reports accepted by the applicable regulatory agencies.
Interface and collaborate within the scope of these responsibilities
- with relevant counterparts in the regional & country pharmacovigilance functions to facilitate electronic distribution/submission to each country contact.
- with data analysts and other functions within PV Technology in all aspects of database maintenance.
- with Safety Operations (document specialists, data coordinators, and safety reviewers) and other functions within Global Pharmacovigilance (GPV) to process adverse events efficiently & reliably.
- with other Baxter groups (e.g. Clinical & Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc), specifically in regards to safety data standards.
Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
Additional responsibilities and projects as assigned

Qualifications:

N/A: Intern or Co-op

Solid knowledge of pharmacovigilance terminology, specifically ICH E2B, and system data entry conventions
Capacity to analyze & resolve problems with analytical & problem solving skills
Strong organizational skills with strong attention to detail
Excellent written & oral communication skills
Operates effectively in a team environment
Global Safety Database knowledge
Solid Technical system skills (e.g. word processing, spreadsheet, databases, and markup languages)
Knowledge of medical terminology

Education and/or Experience:

N/A: Intern or Co-op

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N/A: Intern or Co-op

Bachelor's degree in computer science, life sciences or equivalent
One year of previous experience in Safety Submissions or other area of pharmacovigilance, regulatory affairs and/or clinical research is desired.
Additional job experience in the following areas is relevant: quality assurance, data management, or IT.

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.

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 here and let us know the nature of your request along with your contact information.

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Submission Analyst