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.
Education/Experience:
- 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.
Knowledge/Skills:
- 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.