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Medical Safety Writer

0-2 years
Not Disclosed
10 Nov. 4, 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

Join Us at Baxter—Where You Save and Sustain Lives

At Baxter, our mission drives us. Every role contributes to making a positive impact on the lives of people worldwide, enhancing outcomes for millions of patients. For over 85 years, our products and therapies have been vital in hospitals, clinics, and homes.

We foster a collaborative environment where everyone can thrive and inspire one another. Here, you can truly do your best work.

Position Overview: Medical Safety Writer (MSW)

As a Medical Safety Writer, you will play a crucial role in preparing and completing aggregate safety reports for submission to regulatory agencies around the globe.

Key Responsibilities:

  • Write and prepare 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).
  • Ensure all assigned reports are processed and submitted in accordance with regulatory requirements and internal timelines.
  • Assist in preparing timely responses to regulatory authority requests and assessment reports.
  • Collaborate with Drug Safety Physicians, the EU-QPPV, and GPS Risk Management to address safety issues related to writing activities.
  • Interface with various Baxter functional groups, including Regulatory Affairs, Clinical/Medical Affairs, Quality, and Data Management as needed.
  • Support the creation and maintenance of standardized departmental procedures and processes for Medical Safety Writing.
  • Participate in assigned project teams and committees.

Reasonable Accommodations: Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please let us know how we can help.

Recruitment Fraud Notice: Baxter has identified incidents of employment scams where fraudulent individuals pose as Baxter representatives to obtain personal information. To protect yourself, please refer to our Recruitment Fraud Notice.