Serves as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance
Job Summary
Serves as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
Provides operational oversight of functional teams and projects, monitoring quality of work and efficiency of team members.
Maintains understanding and ensures compliance of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, GVP modules and the drug development process.
Matching Summary
Serves as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
Skills & Requirements
Must-have
Safety and Pharmacovigilance interface
Line management responsibilities
Operational oversight of functional teams
Review study budgets and expenses
Client updates and reports
SOPs and GVP compliance
Nice-to-have
Develop and improve departmental functions
Solicit new business
Participate in audits and inspections
Implement corrective and preventive actions
Key Requirements
BA/BS in biological sciences or related disciplines or equivalent combination of education and experience
Progressive responsibility with demonstrated leadership skills
Project management experience
Clinical Research Organization (CRO) experience preferred