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    Product Safety Specialist

    Lancesoft
    2-4 years
    $ 40.00 to $ 45.00 per hour
    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

    Job Title: Pharmaceutical Drug Safety Specialist (Remote)

    Job Description:

    Pay Rate: $40.00 to $45.00 per hour
    Duration: 12 Months+
    Location: Remote

    Our client is seeking a Pharmaceutical Drug Safety Specialist to manage the receipt and documentation of safety information for marketed and investigational products. This role requires interaction with healthcare professionals and consumers to obtain and follow up on adverse event reports. The position involves coding and entering data into the global safety database while ensuring the accuracy, completeness, and validity of the information. The specialist will also be responsible for ensuring compliance with regulatory submissions and maintaining product knowledge to provide accurate information to healthcare providers and consumers.

    Key Responsibilities:

    1. Data Entry & Case Management (65%):

      • Accurately and timely enter both domestic and foreign adverse event information into the Product Safety Surveillance System (PSSS), in line with the ARISg coding manual, SOPs, process flows, and established timeframes.
      • Perform follow-up on cases as per department guidelines, ensuring thorough communication within the case file.
      • Maintain proficiency in PSSS, including MedDRA coding.

    2. Regulatory Submissions (15%):

      • Ensure accurate and timely submissions to regulators, co-marketing partners, and affiliates within company and regulatory timeframes.
      • Utilize ARISg for reporting and confirming the successful distribution and acknowledgment of submissions.

    3. Product Knowledge & Customer Service (10%):

      • Maintain comprehensive product knowledge to respond to inquiries from consumers and healthcare professionals.
      • Provide high-level customer service by delivering accurate product information to stakeholders.

    4. Training Compliance (10%):

      • Complete all required training within the timelines provided to ensure compliance with corporate and departmental SOPs, SWPs, and WIDs.

    5. Medical Significance Assessment:

      • Gather sufficient information to assess the medical significance of adverse event reports while addressing healthcare provider and consumer concerns.

    Required Qualifications:

    • Bachelor’s Degree in a healthcare-related field.
    • Healthcare professional status (US license not required).
    • Minimum 2-4 years of clinical experience, with at least 1 year in pharmaceutical drug safety.
    • Experience in verbally interviewing or providing medical information to healthcare professionals and consumers.
    • Proficiency in medical terminology and standards of patient care.
    • Strong computer proficiency.

    Important Notes:

    • This role will not involve toll-free phone lines but will function as the "case owner," managing adverse event reports from start to finish.
    • Candidates must be capable of pursuing follow-up information and sending appropriate documentation as needed.

    About LanceSoft:
    LanceSoft is one of the largest and fastest-growing staffing firms in the US, committed to building global connections that strengthen both our employees' careers and our clients' businesses. We provide Global Workforce Solutions with a human touch.

    Employee Benefits:

    • Four options of Medical Insurance
    • Dental and Vision Insurance
    • 401(k) Contributions
    • Critical Illness, Life, and Accident Insurance
    • Additional Employee Perks

    For more information, visit www.lancesoft.com.

    EEO Employer: LanceSoft provides equal opportunity to all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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