Drug Safety Manager

· Cardiff, California
Employment Type Full-Time
Minimum Experience Manager/Supervisor

Viracta Therapeutics is private biotechnology company committed to advancing new medicines to benefit patients with viral-associated cancers and other serious diseases. Viracta’s proprietary platform is a highly targeted combination therapy approach for virus-associated malignancies. Our initial focus is on cancers associated with the Epstein Barr Virus (EBV). We will also expand into additional applications to utilize this approach for a range of cancers and virus-associated diseases.


POSITION DESCRIPTION:

We are currently seeking a Drug Safety Manager to join our experienced drug development team in Cardiff, CA. Remote candidates may be considered, however, in-house is preferred. He/she will oversee day to day safety and pharmacovigilance activity and contribute to the overall strategy for the organization and/or assigned clinical programs. This team member will provide oversight to relevant CROs and consultants in conjunction with the clinical development leadership. We are seeking a strong team player with experience in oncology drug development, strong communication skills, and ability to contribute to a collaborative interdisciplinary environment.


KEY RESPONSIBILITIES:

  • Ensure timely safety reporting to regulatory authorities, Independent Review Boards/Ethics Committees and Investigators in Viracta’s clinical trials
  • Support preparation for, participating in and ensuring adequate follow-up of safety/pharmacovigilance related audits and inspections.
  • Ensure close collaboration and communication with PV vendors on outsourced PV tasks
  • Design and review of Safety Management Plans for each ongoing clinical study to ensure compliance with relevant regulations
  • Maintain internal SAE and PV Master tracker and review e.g. safety CRO compliance reports
  • Review and give input to key study, regulatory and other documents (including but not limited to clinical study protocol and amendments, IBs, master patient information/informed consent forms and clinical study reports)


QUALIFICATIONS:

  • BS or advanced degree preferred in related field
  • Global experience in oncology
  • Superior writing skills.
  • Understanding of GXP (GCP and CVP) compliance and ICH guidelines
  • Strong computer capabilities, including MS Office and role relevant software systems (e.g. Argus)
  • Strong communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment

Thank You

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  • Location
    Cardiff, California
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor