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Safety Scientist - Job # 21-001

Company: NeoImmuneTech, Inc.
Location: Rockville
Posted on: January 16, 2022

Job Description:

  • Remote and Hybrid Opportunities Available!
    Our Company
    NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, founded in 2014 and based in Rockville, MD. Our lead drug candidate, NT-I7 is the only clinical-stage long-acting human IL-7 and is uniquely positioned to address key unmet medical needs in immuno-oncology and infectious diseases. We have partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics, with plans to rapidly expand into additional combinations, such as CAR-T. We are well funded and rapidly expanding our operations and personnel, and looking for strong, highly motivated, and talented individuals to complement our excellent team.
    Job Summary
    The Safety/Pharmacovigilance Scientist provides oversight and monitoring of product safety regarding all programs, develops SOPs to ensure trials are conducted in compliance with regulatory requirements, and directs team of risk and benefit management of study medication.
    Primary Responsibilities

    • Reviews all adverse events (AEs) and serious adverse events (SAEs) for accuracy and consistency, coding and case assessments, and submissions to applicable regulatory authorities
    • Independently applies scientific knowledge and performs literature searches
    • Leads cross-functional training of relevant stakeholders
    • Assists with the evaluation of case data to monitor and identify potential product trends and safety signals
    • Performs periodical safety data review and reports and contributes to safety risk assessments
    • Supports the drug safety related regulatory documents (e.g., IB, DSUR, RMPs, SUSAR reports and CSR)
    • Collaborates with team to develop division SOPs
    • Partners with Quality Assurance to comply with applicable quality and regulatory requirements
    • Works closely with CPM/CTS/CRO to meet deadlines for data review and milestones
    • Other duties as assigned
      Qualifications

      • BS in life sciences; PhD, MD, or MS preferred
      • 3 years of relevant experience in pharmacovigilance, drug safety, regulatory affairs, or clinical trials preferred
      • Demonstrated experience in key activities and responsibilities for the role
      • Working knowledge of statistics and safety data analyses
      • Working knowledge of relevant regulations
      • Excellent written and verbal communication skills
        Benefits
        • 401(k) + company matching
        • Health Insurance - Medical (free), Dental, Vision
        • Life Insurance
        • Paid Time off
        • Paid Holidays
        • Paid Sick Leave
        • Paid Family Medical Leave
          NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
          If you require assistance to complete a job application, please email us at hr@neoimmunetech.com.

Keywords: NeoImmuneTech, Inc., Rockville , Safety Scientist - Job # 21-001, Other , Rockville, Maryland

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