Drug Safety Manager - Quality and Compliance

Safety Manager responsible for Quality and Compliance within our Regulatory reporting division

Responsibilities 

• The implementation of continuous process improvements, delivering efficiency to global projects
• Understanding of pharmacovigilance and safety reporting requirements globally
• Responsible for all aspects of collection, processing and reporting of Serious Adverse Events (SAEs), adhering to all data protection guidelines, Health Insurance Portability and
• Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures 
• Line management responsibility for the Regulatory Submissions team
• Participates in process development, budget reviews, and project management 
• Manages projects to include responsibility for study budgets and expenses; customer invoicing; provision of project updates and reports to sponsors 
• Reviews, advises, and approves drug safety portions of project proposals 
• Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs).

Requirements 

• Strong analytical, problem solving skills
• The ability to manage and facilitate change
• Good man management experience with the skill to lead, develop and motivate a global team
• Degree educated in biological sciences, pharmacology or related disciplines 
• Experience in pharmacovigilance and safety reporting activities (E2B, gateway, local submissions).
• Clinical research/drug safety experience with a CRO 
• Strong line management and project management skills 
• Proven leadership skills 
• Good working knowledge of financial budgets and various financial analysis tools 
• Effective interpersonal communication skills

*LI-NM1