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Senior Specialist Pv

2-3 years
Not Disclosed
10 Sept. 23, 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 Baxter: Where You Save and Sustain Lives

At Baxter, we are united by a mission that makes a meaningful impact on people around the globe. Every role contributes to improving outcomes for millions of patients, giving you a sense of purpose within our organization.

For over 85 years, Baxter has been at the forefront of medical innovation, providing products and therapies used in hospitals, clinics, and homes worldwide. Together, we foster an environment where we inspire one another to excel and make a difference.

About the Role

As a member of the Safety Operations team within Global Patient Safety (GPS), you will serve as a subject matter expert for individual case safety report processing. You will be responsible for ensuring the timely and accurate review, processing, quality control, and reporting of adverse event reports.

Essential Duties and Responsibilities

  • Adverse Event Processing:
    Process reports from various sources, including thorough review and data entry, assessing seriousness, expectedness, causality, and event resolution.

  • Data Management:
    Select the correct suspect drug within the Pharmacovigilance Safety System and ensure accurate data entry and coding in the database.

  • Narrative Writing:
    Write comprehensive narratives that summarize relevant medical information for individual case safety reports.

  • Medical Coding:
    Use standardized medical dictionaries (e.g., MedDRA) to code medical terms accurately.

  • Case Investigation:
    Request investigations to gather necessary medical information, generating queries and tracking follow-ups with reporters and local affiliates.

  • Quality Control:
    Perform quality checks both in-line and retrospectively as needed, ensuring data integrity.

  • Case Cleanup:
    Prepare cases for aggregate reports, ensuring compliance with quality control metrics and participation in NCR/CAPA activities as required.

  • Training and Mentorship:
    Train and mentor new hires, fostering a collaborative team environment.

Qualifications

  • Medical Knowledge:
    Strong foundation in medical and clinical practices.

  • Analytical Skills:
    Excellent problem-solving abilities and attention to detail.

  • Communication Skills:
    Exceptional oral and written communication skills.

  • Interpersonal Skills:
    Collaborative approach to fostering a positive team environment.

  • Independence:
    Ability to work independently under tight deadlines and adapt to changing priorities.

  • Multi-tasking Ability:
    Capable of prioritizing a dynamic workload effectively.

  • Regulatory Knowledge:
    In-depth understanding of worldwide and regional safety regulations.

  • Database Proficiency:
    Experience with Global Safety Databases (e.g., Argus, ARISg).

  • Therapeutic Knowledge:
    Familiarity with multiple therapeutic areas and source types.

Education and Experience

  • Degree:
    Bachelor’s degree in Nursing, Pharmacy, Science, or a related field.

  • Experience:
    Minimum of 3 years in Pharmacovigilance, with 2-3 years of hospital or patient care experience preferred.

Reasonable Accommodations

Baxter is dedicated to providing reasonable accommodations for individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please click here to let us know your needs and provide your contact information.

Recruitment Fraud Notice

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Join us at Baxter, where your purpose accelerates our mission of saving and sustaining lives!