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    Pharmacovigilance Senior Specialist

    Pharmalex
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 18, 2024
    Job Description
    Job Type: Full Time 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

    Pharmacovigilance Specialist – Eastern US Region (EST/CST) - PharmaLex

    Key Responsibilities and Activities:

    • Support the creation of Individual Case Safety Reports (ICSRs) for adverse drug reactions from clinical trials, spontaneous reporting systems, and literature; report ICSRs to competent authorities.
    • Assist with the generation, processing, documentation, and tracking of follow-up requests.
    • Ensure timely and accurate CIOMS / MedWatch deliverables.
    • Assist with database reconciliation activities.
    • Screen and document scientific literature related to safety-relevant publications.
    • Document case processing on both company and case levels.
    • Provide support for Medical Information intake, documentation, quality control, and reconciliation services.
    • Handle customer inquiries or complaints per quality assurance requirements.
    • Monitor inbound mailboxes and assist with case triage to case processing teams.
    • Contribute to the creation of periodic reports, including PSURs, DSURs, PADERs, risk management plans, and signal detection reports.
    • Lead client and internal operational meetings to ensure quality, compliance, and timeliness.
    • Contribute to/review QA documents, such as Working Instructions, SOPs, Working Procedures, templates, and project metafiles for PharmaLex pharmacovigilance projects.
    • Organize and conduct training on QA documents.
    • Perform quality control tasks, including ICSR processing quality checks and other project-specific checks.
    • Support initiation and closure of any project-related deviation and CAPA issues.
    • Prepare for and participate in internal and external audits/inspections.
    • Perform other duties as assigned.

    Required Education, Experience, Skills, and Competencies:

    • Bachelor’s degree in Life Science, Nursing, or Pharmacy and 5-7 years of experience, or an equivalent combination of education and experience.
    • Minimum 5 years of experience in a CRO/Pharma/Biotech safety department.
    • Excellent knowledge and experience with pertinent legislation and regulatory frameworks (GVP/CFR).
    • Strong clinical and post-marketing pharmacovigilance experience.
    • Ability to manage and execute various safety-related operating procedures.
    • Ability to prioritize work according to competing timelines and client needs.
    • Proven ability to work under tight deadlines.
    • Project management skills.
    • Excellent customer service and communication skills.
    • Ability to adapt to regularly changing conditions.
    • Strong organizational, analytical, and problem-solving skills.
    • Excellent written and verbal communication skills in English.

    We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, marital status, gender identity, or any other status protected under applicable law.

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