Career Summary Pharmacovigilance Director of consumer care division with an in-depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance-driven environment. An articulate and positive communicator with proven effective management of staff, workload, vendors and associated processes to maintain exceptional quality, consistency and compliance with regulatory requirements and partner contracts. A Breakthrough Leader with strengths in cross-functional leadership skills that have led to successful Rx-to-OTC switches, product line extensions, and global product launches.

Highlights:

• Documentation
• Management
• Regulatory Affairs
• Compliance
• Integrate
• Outsourcing
• Quality
• Risk Management
• Triage
• Audit
• pharmaceutical
• regulatory
• Drug safety
• clinical trials
• research