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Pssr-Associate I, Safety Assessment_Japanese

0-2 years
Not Disclosed
10 Dec. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Safety Data Analyst
Location: On Premise
Type of Position: Full-Time


Position Purpose

The Safety Data Analyst supports Pfizer's commitment to patient safety by processing, analyzing, and documenting adverse event (AE) and serious adverse event (SAE) reports. The role ensures regulatory compliance while contributing to the safety profile of Pfizer's products.


Primary Responsibilities

  1. Case Processing:

    • Identify and prioritize routine cases for processing and document reasons for any delays.
    • Assess cases for complexities and escalate as needed.
    • Review and document key case attributes, including validity, seriousness, and reportability criteria.
  2. Case Management:

    • Write and edit case narratives for accuracy and consistency.
    • Determine appropriate follow-up and request additional information when required.
    • Ensure adherence to regulatory compliance timelines for report generation.
  3. Collaboration and Communication:

    • Liaise with internal and external stakeholders, including Pfizer Country Organizations, Clinical Development, and License Partners, for safety data collection and reconciliation.
  4. Regulatory Knowledge and Application:

    • Develop expertise in Pfizer products, global regulations, Standard Operating Procedures (SOPs), and safety database functionalities.
    • Consistently apply regulatory requirements and Pfizer policies to all activities.
  5. Continuous Learning:

    • Maintain updated knowledge of the Pfizer portfolio and the evolving regulatory landscape.

Technical Skill Requirements

  • Experience in pharmacovigilance, clinical care, or scientific research is advantageous but not mandatory.
  • Proficiency in relational database management.
  • Excellent oral and written communication skills.
  • Fluency in English; proficiency in Japanese (N2 level or above) required.
  • Medical writing experience is a plus.

Qualifications

  • Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualifications preferred.
  • Ability to solve routine problems and make basic decisions with an understanding of potential outcomes.
  • Demonstrated ability to meet departmental performance standards and work effectively under supervision within a matrix organization.

Equal Employment Opportunity

Pfizer is committed to fostering an inclusive and diverse workplace, ensuring equal opportunities for all candidates.


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