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Drug Safety Manager (REMOTE)

Company: Actalent
Location: Gaithersburg
Posted on: March 20, 2023

Job Description:

Position Summary: Responsible for supporting pharmacovigilance operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements. Responsible for building effective relationships with vendors, and other external and internal partners. Key Responsibilities:

  • Interacts with case processing vendor on regular basis to ensure timely processing of adverse events reports for all investigational and marketed products.
  • Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution.
  • Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics.
  • Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
  • Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to internal PV Ops deliverables.
  • Ensures development and maintenance of applicable SOPs, Working Practices and trainings.
  • Frequently interacts with collaborators, and functional peer groups at various management levels within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules. Requirements:
    • Bachelor's degree in life sciences
    • PharmD, RN, BSN preferred
    • Approximately five (5) years of experience in drug safety / pharmacovigilance experience
    • Minimum three (3) years working with a CRO / Sponsor
    • Sponsor experience preferred About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Washington DC , Drug Safety Manager (REMOTE), Executive , Gaithersburg, DC

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