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    Global Safety Operations Contract Specialists

    Propharma
    5+ years
    Not Disclosed
    Remote
    10 Aug. 14, 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: Senior Pharmacovigilance Specialist

    Job Description:

    The Senior Pharmacovigilance Specialist will oversee and ensure the quality and compliance of adverse event data collection and reporting. This role involves conducting medically focused reviews of expedited and high-interest safety reports, preparing regulatory submissions, monitoring data corrections, performing quality control (QC) on adverse event reports, reconciling serious adverse events (SAEs), and managing compliance metrics for license partner data exchanges. Extensive experience with the Argus safety database and pharmacovigilance case processing workflows is essential for success in this role.

    Key Responsibilities:

    Clinical Trial Adverse Event Reporting:

    • Manage the reporting of adverse events from clinical trials.
    • Ensure reporting is timely and accurate, adhering to regulatory requirements.

    Medical Review of Expedited Safety Reports:

    • Perform detailed medical reviews of expedited safety reports and high-interest events, including causality assessments.
    • Evaluate the clinical significance of adverse events and ensure proper follow-up actions and queries are addressed.

    Preparation of Regulatory Submissions:

    • Prepare and review safety-related regulatory submissions.
    • Ensure accuracy, compliance, and timely submission of all documents.
    • Construct analysis of similar events (AOSE) summaries to meet FDA expedited submission regulations.

    Corrections Monitoring:

    • Track and monitor the correction of safety reports to maintain data integrity.
    • Implement process improvements based on data trends to minimize errors and compliance risks.

    Quality Control (QC) of Adverse Event Reports:

    • Conduct QC checks on individual case safety reports to ensure completeness and accuracy.
    • Identify and resolve discrepancies or issues in the reports.
    • Provide feedback to case processing vendors based on QC findings and participate in vendor training support meetings.

    Reconciliation:

    • Oversee clinical trial reconciliation to ensure accurate event capture in the COMPANY Safety database.
    • Work with clinical teams to address and resolve discrepancies.

    License Partner Compliance Metrics:

    • Monitor and manage compliance metrics for license partners.
    • Ensure adherence to safety reporting requirements and standards by all partners.

    General Safety Operations Oversight:

    • Assist with oversight and respond to inquiries related to ICSRs from clinical trials, post-marketing solicitations, and spontaneous sources.
    • Support deviation investigations, root cause analyses, and corrective actions.
    • Assist with backroom activities during audits and inspections.

    Education Requirements:

    • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field. Preference for candidates with a nursing degree and associated clinical judgment.

    Required Experience:

    • Minimum of 5 years in pharmacovigilance or drug safety, with pharmaceutical experience being a plus.
    • Extensive experience with the Argus safety database and case processing workflows.
    • Strong knowledge of global regulatory requirements for safety reporting.
    • Proven experience in clinical trial adverse event reporting, quality control, and assessment.
    • Experience in preparing regulatory submissions and ensuring compliance.
    • Excellent analytical and problem-solving skills with attention to detail.
    • Strong written and verbal communication skills.
    • Ability to work independently and as part of a multidisciplinary team.
    • Strong organizational and time management skills to handle multiple tasks and projects simultaneously.

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