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.
Essential Duties and Responsibilities
Responsibilities include, but are not limited to the following :
The Medical Safety Writer (MSW) is responsible for the preparation and completion of aggregate safety reports for submission to regulatory agencies worldwide.
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
Demonstrate solid understanding of the role of internal policies, conventions and procedures in completing report assignments
Facilitate document review by other contributors
Perform quality control reviews of aggregate safety reports
Ensure data issues are addressed and resolved prior to document sign-off
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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and / or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Bachelor’s degree (or higher) in a medical / scientific field or 2(+) years pharmaceutical industry experience
Experience writing in an academic research, clinical research, scientific / analytical, or medical affairs setting is a plus
Pharmacovigilance experience is a plus
Excellent scientific / clinical writing and editorial skills
Excellent verbal and written communication skills in mother tongue and English (if not mother tongue)
Familiarity with medical terminology and scientific writing
Good numeracy skills
Highly proficient computer skills and familiar with electronic publishing
Ability to manage several assigned aggregate safety reports / projects at the same time
Demonstrate excellent time management skills
Solid understanding of pharmacovigilance regulation requirements for aggregate safety report preparation and drug approval processes
Ability to perform detailed scientific analysis / evaluation of specialized information to support decision making
Editing proficiency including experience with document formatting (spelling, punctuation, capitalization, paragraph indentation, organization, style and conventions) for submission readiness
Demonstrate the ability to respond to and resolve inquiries and problems relating to assigned aggregate safety reports
Operates effectively in a global team environment