Medical Safety Writer
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1 Vacancy
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
Purpose
The Medical Safety Writer (MSW) is responsible for the preparation and completion of aggregate safety reports for submission to regulatory agencies worldwide.
Essential Duties and Responsibilities
Write and prepare standalone post-marketing aggregate safety reports such as Periodic Adverse Drug Experience Reports (PADERs) Periodic Benefit Risk Evaluation Reports (PBRERs) Periodic Safety Update Reports (PSURs) and associated reports for regulatory submission; perform quality control reviews of aggregate safety reports.
Ensure all assigned aggregate safety reports are processed and submitted according to regulatory requirements and internal timelines.
Assist in the preparation of timely function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities.
Collaborate with Drug Safety Physicians EU-QPPV and GPS Risk Management Head/Specialist concerning safety issues relative to safety writing activities.
Interface with other Baxter functional groups such as Regulatory Affairs Clinical/Medical Affairs Quality Data Management or other business units as needed.
Support the creation improvement and maintenance of Medical Safety Writing standardized departmental procedures and processes.
Participate on assigned project teams and committees.
Qualifications
Education
Bachelors or Masters degree in Pharmacy or Life Sciences (or equivalent scientific discipline).
Experience
2 to 6 years of relevant experience in Medical Safety Writing
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 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.
About Company
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 ... View more
