Ariela Chick
Sr Strategic Pv Advisor @Perspective Pharmacovigilance, Inc
Signup · Get unlimited contacts
WORK HISTORY
Sr Strategic Pv Advisor @Perspective Pharmacovigilance, Inc
US
Manage a small group of PV consultants for various global client projects. Focus on strategy and successful delivery and tracking of major PV deliverables, PV Ops and Compliance work, helping prepare companies for NDA/BLA and MAA PV obligations and general PV inspection readiness. Also support RFP/selection of safety CROs and/or consideration of different global safety database models.
EDUCATION
University of California, Berkeley
MPH, Infectious Diseases
UC Irvine
B.S., Biological Sciences
SKILLS
ABOUT ARIELA CHICK
Research & pharmacovigilance professional with over 20 years of relevant experience in pharmacovigilance. Experience includes REMS program management, PV vendor management & oversight, safety operations budget management, GCP/GPvP audit/inspection preparedness, safety data exchange agreement (SDEA) negotiations and management, PV training and standard operating procedure (SOP) development and maintenance, and management of global ICSR and aggregate safety report submissions to FDA, EMA and across Asia Pacific regions. Specialties: Line management, contract development & negotiation, business alliance and/or vendor management, strong knowledge of quality management system requirements for maintenance of global pharmacovigilance compliance, PSMF, leadership of drug-safety related audits and/or regulatory agency inspections, project management skills
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.