Director, Drug Safety Operations

Salary $210,000-$297,500 base
Employment type Permanent

Job description

Director, Drug Safety Operations

Location: Alameda, CA or King of Prussia, PA

Summary: Oversee all aspects of drug safety study operations from start-up to close-out. Manage case workload distribution, coordinate multiple safety projects, and liaise with partners and cross-functional teams.

Key Responsibilities:

  • Collaborate with stakeholders (Clinical Development, Operations, Data Management, Medical Affairs, Regulatory Affairs) for safety data collection and handling.
  • Liaise with Drug Safety vendors and partners to meet global regulatory requirements for SAE reporting.
  • Develop/update SOPs for safety data collection in line with regulations and ICH standards.
  • Coordinate workload distribution with the Drug Safety Workflow Manager.
  • Ensure proper scheduling of case reports in Argus.
  • Staff and train the functional area with necessary employees, consultants, and temporary workers.
  • Oversee processes and workflows for safety data processing.
  • Support Drug Safety Study Team Leads in reviewing protocols, case report forms, and participation in IND Annual Reports.
  • Assist with metrics, budget forecasting, and headcount needs.
  • Perform additional duties as required.

Supervisory Responsibilities:

  • Directly supervise employees.
  • Indirectly supervise through subordinate supervisors or a dotted line structure.


  • BS/BA in a related field with 13+ years of experience, or
  • MS/MA with 11+ years of experience, or
  • PhD with 8+ years of experience, or
  • Equivalent education and experience.

Ideal Experience:

  • Required: Drug Safety and Operations experience.
  • Preferred: Experience with Argus safety database.


  • In-depth knowledge of biotech/pharmaceutical practices.
  • Strong understanding of international regulations and guidelines for clinical trial and post-marketing safety.
  • Excellent problem-solving, organizational, and planning skills.