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    Senior Safety Surveillance Associate

    Pfizer
    2+ years
    Not Disclosed
    India
    10 Oct. 7, 2024
    Job Description
    Job Type: Remote 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

    Primary Responsibilities:

    • Identify and select routine cases for processing, establishing appropriate prioritization criteria and documenting reasons for any delays.
    • Assess cases to identify complexities and escalate issues as necessary.
    • Review, rank, verify, process, and document event terms, case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaint information, reportability with due dates, and ensure accuracy and consistency based on case assessments.
    • Evaluate case criteria to determine the correct workflow for processing.
    • Write and edit case narratives.
    • Generate reports while adhering to regulatory compliance timelines.
    • Determine appropriate case follow-up, including requesting follow-up letters when necessary.
    • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and reconciliation.
    • Develop and maintain expertise in all products within the Pfizer portfolio, as well as relevant corporate and global regulations, guidelines, Standard Operating Procedures, writing practices, data entry conventions, and database search functions.
    • Consistently apply regulatory requirements and Pfizer policies.

    Technical Skill Requirements:

    • Experience in pharmacovigilance, clinical care, or clinical/scientific research is preferred but not mandatory.
    • Strong computer literacy, especially in managing relational databases.
    • Ability to achieve personal objectives while meeting departmental performance standards.
    • Capability to work under supervision in a matrix organization.
    • Excellent oral and written communication skills.
    • Fluency in spoken and written English; knowledge of additional languages is an advantage.
    • Experience and skills in medical writing are a plus.

    Qualifications:

    • Health Care Professional background (e.g., Pharmacy, Dentistry, Nursing).
    • Pharmacovigilance or relevant experience: 0-6 years.

    Work Location Assignment: Flexible

    Pfizer is an equal opportunity employer and adheres to all applicable equal employment opportunity legislation in each jurisdiction where it operates.

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