Director, Drug Safety Operations Job at GQR, Pennsylvania

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  • GQR
  • Pennsylvania

Job Description

Job Title: Director, Drug Safety Operations

Location: San Fran, CA or Philly, PA (Onsite 5 days a week)

Company Overview: A leading biotechnology company specializing in oncology-focused therapies, we are at the forefront of innovative drug development. Join us as we expand our focus to include immuno-oncology and biologics.

Job Summary: We are seeking an experienced Director of Drug Safety Operations to oversee drug safety study operations from start-up to close-out. This role involves managing case workload distribution, coordinating multiple safety projects, and liaising with partners and cross-functional teams to ensure compliance with global regulatory requirements.

Key Responsibilities:

  • Collaborate with internal stakeholders and external partners for safety data collection and handling.
  • Manage relationships with Drug Safety vendors to meet global SAE reporting requirements.
  • Develop and update SOPs in line with regulations.
  • Oversee processes and workflows for safety data processing.
  • Support review of protocols and participation in IND Annual Reports.
  • Assist with metrics, budget forecasting, and headcount needs.

Qualifications:

  • BS/BA in a related field with 13+ years of experience, MS/MA with 11+ years, or PhD with 8+ years, or equivalent.
  • Extensive experience in Drug Safety and Operations.
  • Strong operational and team management experience.
  • Preferably experience with the Argus safety database.
  • Local to CA or PA preferred.

Apply Today!

Job Tags

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