As a Medical Safety Writer (MSW) at Baxter, you will be responsible for preparing and completing aggregate safety reports for regulatory submission. You will collaborate with multiple teams, including Drug Safety Physicians and Regulatory Affairs, to ensure that reports such as Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), and others are submitted in compliance with regulatory requirements and internal timelines.
Key Responsibilities:
- Write and prepare post-marketing aggregate safety reports, including PADERs, PBRERs, PSURs, and associated reports for regulatory submissions.
- Perform quality control reviews of safety reports.
- Ensure all assigned reports are processed and submitted according to regulatory standards and deadlines.
- Assist in preparing timely responses to regulatory authority requests and assessments.
- Collaborate with Drug Safety Physicians, EU-QPPV, and other departments concerning safety writing activities.
- Interface with internal groups, such as Regulatory Affairs, Clinical/Medical Affairs, Quality, and Data Management.
- Support and improve departmental procedures and processes.
- Participate in project teams and committees as assigned.
Qualifications:
- Bachelor’s degree in a healthcare-related field or relevant experience in medical writing.
- Strong knowledge of regulatory requirements for safety report writing.
- Excellent communication, organizational, and analytical skills.
- Ability to work in a collaborative, cross-functional team environment.
Why Join Baxter?
At Baxter, our mission is to improve patient outcomes worldwide by pioneering significant medical innovations. Our work can be found in almost every hospital, clinic, and home, impacting millions of lives daily. With over 85 years of healthcare innovation, we are committed to creating a culture where employees thrive, feel a sense of purpose, and can perform their best work.
