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    Drug Safety Operations Associate - Remote / Telecommute

    Cynet Systems
    3-5 years
    $48.36 to $53.36 per hour
    Remote, USA
    10 Sept. 27, 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

    Job Description

    Pay Range: $48.36/hr - $53.36/hr

    Responsibilities:

    • Perform case processing activities, including triage, data entry, and report distribution as needed.
    • Assess and process all adverse event (AE) case types to ensure compliance with regulatory requirements.
    • Triage cases to prioritize as requested by the company.
    • Identify adverse events, their seriousness, and their labeled status for proper case assessment, reviewing incoming information for reportability.
    • Select the appropriate causality assessments (as-reported and company causality).
    • Conduct all necessary coding using MedDRA, WHO-DRUG, and company-specific product dictionaries.
    • Create and manage case narratives as needed for medical orientation.
    • Determine follow-up requirements and initiate requests for additional information via email, phone, or letters.
    • Execute CRO case quality control activities, including reconciliation as required.
    • Support Individual Case Safety Report (ICSR) submissions and transmissions as needed.
    • Work on high-priority or assigned cases using the Workflow Management System or as directed.
    • Participate in inspections and audits, including providing requested data and participating in interviews.
    • Meet key performance indicators (KPIs) and quality indicators (KQIs) as set by the company, adhering to guidelines and policies.
    • Assist in writing late ICSR-related deviations and corrective and preventive actions (CAPAs) as requested.
    • Perform additional tasks as assigned, working independently to assess issues, propose solutions, and escalate matters internally as appropriate.

    Education and Experience Requirements:

    • Bachelor’s degree in a life science or healthcare field (advanced degree preferred).
    • Minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company.
    • At least 3 years of experience in Drug Safety Operations.
    • Experience overseeing CRO teams of case processors is preferred.

    Knowledge, Skills, and Abilities:

    • Strong resource and workflow management skills, with the ability to monitor and assign tasks effectively.
    • Proficient in MedDRA coding.
    • Ability to consider both present and future impacts when making recommendations.
    • Strong negotiation and problem-solving skills.
    • Excellent analytical skills and attention to detail.
    • High accountability and ownership of deliverables.

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