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Ct Platform Safety Associate

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 Purpose
The role involves reviewing, preparing, and completing clinical study and compassionate-use sourced adverse event (AE) and serious adverse event (SAE) reports to determine the safety profile of Pfizer's products and fulfill regulatory requirements.


Primary Responsibilities

  • Perform case intake, data entry, and processing activities.
  • Assess cases to identify complexities or issues, escalating when necessary.
  • Select cases for data entry, prioritize appropriately, and document any delays.
  • Review, rank, process, and document case-related details, including event terms, classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaints, reportability, and due dates. Route cases to the correct workflow.
  • Draft and edit detailed case narratives.
  • Verify processed cases for accuracy, consistency, and compliance, including special scenarios.
  • Apply regulatory requirements and Pfizer policies to assess the reportability of cases, generate reports, and meet compliance timelines.
  • Conduct appropriate follow-ups for cases, including generating follow-up request letters.
  • Collaborate with key stakeholders, including:
    • Global Pharmacovigilance Organization
    • Pfizer Safety Surveillance and Reporting Centers of Excellence
    • Clinical Development teams
    • License partners and others involved in AE/SAE collection, data reconciliation, and distribution/submission.
  • Contribute to internal and external safety-related activities as needed.
  • Develop and maintain expertise in Pfizer’s product portfolio, corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and safety database search functions.

Technical Skill Requirements

  • Preferred but Not Required: Experience in pharmacovigilance, clinical care, or clinical/scientific research.
  • Demonstrated computer literacy, especially in managing relational databases.
  • Strong oral and written communication skills.
  • Fluency in spoken and written English; knowledge of additional languages is an advantage.

Qualifications

  • Education: Bachelor’s degree in a science-related field (e.g., pharmacy, nursing) or equivalent; healthcare professional qualifications are preferred.
  • Ability to:
    • Solve routine problems with supervision and escalate issues constructively.
    • Make basic decisions while understanding their potential consequences.
    • Achieve personal objectives while adhering to departmental performance standards.
    • Operate effectively under supervision in a matrix organization.

Work Location Assignment

Hybrid


Equal Employment Opportunity
Pfizer is an equal-opportunity employer and adheres to all applicable equal employment opportunity legislation in the jurisdictions where it operates.

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