Medical Safety Writer

Baxter

2+ years

Not Disclosed

Ahmedabad

10 Oct. 14, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Safety Writer
Req # JR - 150046
Location: Ahmedabad, Gujarat, India
Job Category: GST Operations
Date Posted: 10/10/2024

Join Baxter, Where Every Role Matters

At Baxter, our mission is to save and sustain lives. Every member of our team plays a crucial role in improving outcomes for millions of patients worldwide. You’ll find purpose in your work as we collectively strive to enhance healthcare.

With over 85 years of pioneering medical innovations, Baxter's products and therapies are integral to hospitals, clinics, and homes across the globe. We foster an inspiring environment where success and collaboration thrive. Here, you can make a meaningful impact.

Position Overview

The Medical Safety Writer (MSW) is responsible for preparing and completing aggregate safety reports for regulatory submission worldwide. Key responsibilities include:

Writing and preparing standalone post-marketing aggregate safety reports, including Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Periodic Safety Update Reports (PSURs).
Conducting quality control reviews of aggregate safety reports to ensure compliance with regulatory requirements and internal timelines.
Assisting in timely responses to regulatory authority requests and assessment reports.
Collaborating with Drug Safety Physicians, the EU-QPPV, and the GPS Risk Management Head/Specialist on safety writing activities.
Working with various Baxter functional groups, including Regulatory Affairs, Clinical/Medical Affairs, and Quality, as needed.
Supporting the development and maintenance of standardized departmental procedures for Medical Safety Writing.
Participating in assigned project teams and committees.

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities throughout the application and interview process. If you need assistance due to a medical condition or disability, please click here and share your request along with your contact information.

Protect Yourself Against Recruitment Fraud

Baxter has identified instances of employment scams where fraudulent parties impersonate Baxter employees to steal personal or financial information. To safeguard yourself, please review our Recruitment Fraud Notice.

Join us at Baxter, where your contributions help save and sustain lives!

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Medical Safety Writer

Job Description

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