Planning, executing and reporting of GCP (investigators, vendors, systems, processes) and GVP (sytems, processes, vendors, business partners) audits, in- process and qualification. Regulatory inspection preparation and support. Experience in North and South America and Europe, auditing systems against FDA, EMA and local regulations.

Overseeing quality program. Acting as the main resource for quality and compliance issues and responsible for further developing, implementing and maintaining the quality program.

New York, NY
Applying quality assurance expertise to the auditing process. Leading, planning,
conducting and reporting of GCP vendor audits, Phase I to IV, on a global scale. Providing Quality and Compliance advice and feedback within various clinical programs

Nutley, NJ
Applying quality assurance expertise to the auditing process. Leading, planning,
conducting and reporting audits in Clinical Operations, Phase I to IV, and Pharmacovigilance, on a global scale, both internally and at investigator sites, contract organizations / vendors, and laboratories (Lead and Co Auditor)

Backup to Local Safety Responsible, collecting, processing and reporting to the local Health Authority domestic and foreign adverse events to marketed and investigational (bio)pharmaceuticals, liaising with health care professionals, consumers, Health Authorities and global counterparts to ensure the appropriate management and distribution of information globally and within regulatory timelines, responding to drug safety queries from HCPs, screening of Canadian literature, training of drug safet