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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

This is Where You Save and Sustain Lives

At Baxter, our mission unites us. Every role makes a meaningful impact on people around the world, enhancing outcomes for millions of patients. With over 85 years of pioneering medical innovations, our products and therapies are integral to hospitals, clinics, and homes globally.

We cultivate a collaborative environment where we inspire each other to succeed. Here, you can do your best work.

Join Us at the Intersection of Saving and Sustaining Lives—Where Your Purpose Accelerates Our Mission

Position Overview: Medical Safety Writer (MSW)

The Medical Safety Writer is responsible for the preparation and completion of aggregate safety reports for submission to regulatory agencies worldwide.

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), while performing quality control reviews.
  • Ensure timely processing and submission of all assigned aggregate safety reports in accordance with regulatory requirements and internal deadlines.
  • Assist in preparing prompt responses to regulatory authority requests and assessment reports.
  • Collaborate with Drug Safety Physicians, the EU-QPPV, and the GPS Risk Management team regarding safety writing activities.
  • Interface with various Baxter functional groups such as Regulatory Affairs, Clinical/Medical Affairs, Quality, and Data Management as needed.
  • Support the creation and maintenance of standardized procedures and processes for Medical Safety Writing.
  • Participate in assigned project teams and committees.

Reasonable Accommodations: Baxter is dedicated to providing reasonable accommodations to individuals with disabilities. If you need 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 instances of employment scams where fraudulent parties impersonate Baxter employees to obtain personal information. To protect yourself, please review our Recruitment Fraud Notice.