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Assoc, Pv

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 in Saving and Sustaining Lives at Baxter

At Baxter, our mission is deeply ingrained in everything we do. Every role within our organization contributes to making a positive impact on people’s lives around the world. Here, you will find a sense of purpose, knowing that your work enhances outcomes for millions of patients.

For over 85 years, Baxter has pioneered significant medical innovations that transform healthcare, with our products and therapies present in nearly every hospital globally, as well as in clinics and homes. Together, we cultivate an environment where everyone can thrive, support each other, and do their best work.

Position Overview

This role is part of the Safety Operations team within Global Patient Safety (GPS). As a team member, you will process individual case safety reports and serve as the case owner for adverse event reports, ensuring timely, accurate review, processing, quality control, and reporting.

Essential Duties and Responsibilities:

  • Process adverse event reports from various sources, including thorough data entry and assessment of seriousness, expectedness, causality, and overall resolution.
  • Accurately select the suspect drug within the Pharmacovigilance Safety System.
  • Write detailed narratives summarizing all relevant medical information for individual case safety reports.
  • Code medical terms using standardized medical dictionaries (e.g., MedDRA).
  • Ensure all data is entered and coded correctly in the database, leveraging your medical expertise.
  • Coordinate case investigations to gather necessary medical information, including query generation and follow-up with reporters in collaboration with local affiliates.
  • Perform quality checks and case clean-up as needed for aggregate report preparation.

Qualifications:

  • Medical and clinical knowledge.
  • Excellent oral and written communication skills.
  • Effective team collaboration.
  • Ability to work independently under tight deadlines and shifting priorities, with some supervision.
  • Strong multitasking and prioritization skills in a dynamic environment.
  • Familiarity with worldwide and regional safety regulations.
  • Proficiency in the Pharmacovigilance Safety System.

Education and Experience:

  • Degree in nursing, pharmacy, science, or a related field.
  • Experience in the pharmaceutical industry (regulatory or safety) is preferred.
  • 2-3 years of experience in hospital or patient care settings is preferred.

Reasonable Accommodations: Baxter is dedicated 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 encountered incidents of employment scams where fraudulent individuals pose as Baxter representatives to obtain personal information. For information on how to protect yourself, please refer to our Recruitment Fraud Notice.