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    Safety Surveillance Associate

    Pfizer
    2+ years
    Not Disclosed
    Philadelphia Philippines
    10 Nov. 13, 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

    Position Title: Associate – Pharmacovigilance
    Location: Hybrid
    Reports To: Pharmacovigilance Manager

    Why Patients Need You

    Pfizer Worldwide Medical and Safety colleagues are instrumental in providing evidence-based medical decision support, ensuring the safe and appropriate use of medicines. Our mission is to empower healthcare decisions, ensuring better health outcomes for patients by providing scientifically sound frameworks, unbiased medical expertise, and investigating data gaps.

    What You Will Achieve

    As an Associate, you will contribute to monitoring Pfizer's drug, biologics, and medical device surveillance programs. This includes evaluating, processing, and reporting adverse events, supporting clinical trials, and post-marketing activities. Your commitment and domain knowledge will foster a collaborative environment, helping the team achieve project milestones and goals. Your dedication will ensure that Pfizer’s customers and patients receive the medicines they need, when they need them.

    How You Will Achieve It

    • Contribute to the completion of project milestones by organizing your work to meet deadlines.
    • Provide expertise to project teams on regulatory requirements and corporate policies governing regulatory submissions.
    • Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and assisting with related activities.
    • Review case criteria to determine appropriate workflows for case processing.
    • Write, edit, and review adverse event case narratives.
    • Generate reports while ensuring adherence to regulatory compliance timelines.
    • Perform appropriate case follow-up, including generating and requesting follow-up letters.
    • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders, to ensure safety data collection and reconciliation.

    Position Purpose

    The role involves reviewing, preparing, and completing reports on adverse drug experiences, determining the safety profile of Pfizer’s products, and ensuring compliance with regulatory requirements.

    Responsibilities

    • Identify and select routine cases for processing, prioritize based on set criteria, and note any delays.
    • Assess cases to identify those with complexities or specific issues, escalating them appropriately.
    • Process and document event terms, case classifications (validity, seriousness, expectedness, listedness), special scenarios, product complaints, reportability with due dates, and ensure accuracy and consistency.
    • Write and edit case narratives based on assessments.
    • Ensure compliance with regulatory timelines while generating reports.
    • Collaborate with internal and external partners to facilitate safety data collection and data reconciliation.
    • Maintain expertise in assigned products, applicable global regulations, guidelines, and Pfizer policies.
    • Consistently apply regulatory requirements and Pfizer’s policies across all processes.

    Qualifications

    Must-Have

    • Bachelor’s degree in a science-related field (Pharmacy, Nursing, etc.)
    • Healthcare professional qualification required
    • Ability to solve routine problems with supervision and raise issues constructively
    • Basic decision-making abilities with an understanding of consequences
    • Fluency in spoken and written English

    Technical Skills

    • Experience in pharmacovigilance, clinical care, or clinical/scientific research is advantageous but not required
    • Proficiency in computer systems and relational databases
    • Ability to meet personal objectives while adhering to departmental performance standards
    • Ability to work effectively in a matrix organization
    • Excellent oral and written communication skills
    • Experience with medical writing is an advantage

    Work Location

    Hybrid

    Equal Employment Opportunity

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

     

     

     

     

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