Director, Drug Safety Operations
, PA, United States
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!
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