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    Safety Specialist

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Remote, USA
    10 June 27, 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, 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

    Job Description

    Position Overview: Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. Responsibilities include collection, monitoring, assessment, evaluation, research, and tracking of safety information. The role involves coordinating and performing PV activities such as data entry, coding, assessment of adverse events, case review, follow-up, tracking reports, and regulatory reporting. Effective collaboration with project team members, client contacts, investigators, adverse event/reporters, and third-party vendors is essential. The position may also involve preparing departmental and project-specific procedures, attending audits, and participating in kick-off and investigator meetings.

    Essential Functions:

    • Perform day-to-day PV activities, including potential on-call duties to ensure 24-hour coverage for case intake.
    • Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
    • Maintain medical understanding of applicable therapeutic areas and disease states.
    • Review cases for quality, consistency, and accuracy, including peer report reviews.
    • Prepare and maintain regulatory safety reports.
    • Assist with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including client/investigator meetings and reviewing metrics and budget considerations.
    • Mentor less experienced staff.

    Education and Experience:

    • Bachelor's degree or equivalent relevant formal academic/vocational qualification.
    • Minimum of 2+ years of relevant experience.
    • Equivalent combinations of education, training, and/or directly related experience may be considered.

    Knowledge, Skills, and Abilities:

    • General understanding of pathophysiology and disease processes.
    • Detailed knowledge of relevant therapeutic areas for processing adverse events.
    • Strong critical thinking and problem-solving skills.
    • Good oral and written communication skills, including paraphrasing.
    • Proficiency in English and ability to translate information into the local language if required.
    • Computer literate with the ability to work within multiple databases.
    • Familiarity with Microsoft Office packages (Outlook, Word, Excel).
    • Understanding the importance of and compliance with procedural documents and regulations.
    • Ability to manage and prioritize tasks, meet strict deadlines with limited supervision.
    • Strong attention to detail.
    • Ability to maintain a positive and professional demeanor in challenging circumstances.
    • Ability to work effectively within a team to achieve shared goals.

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