Cristina Damatarca

Cristina Damatarca, M.D., PgD, is the Senior Vice President and Global Head of Drug Safety and Pharmacovigilance at Spyre. She is a physician-scientist with over 20 years' experience in the biopharmaceutical industry across all stages of development and product commercialization and has worked in drug safety in multiple leadership capacities, most with global responsibilities.

Cristina received a medical degree from the UMF in Iasi, Romania, and a PgD in Pharmacovigilance from the University of Hertfordshire in the UK.

Cristina held positions as Senior / Vice President & Global Head of Drug Safety and Pharmacovigilance at several pharmaceutical companies of various sizes (Abivax, Xenon, Adagio, Genentech/Roche, Amgen, Intercept, Amylin); she has built multiple safety departments from the ground up, and played key roles in cross-functional collaborations for safety evaluation and benefit-risk assessment. During her tenure in the biopharmaceutical industry, Cristina participated in several successful NDA/BLA/MAA filings, global launches, Drug Advisory Committees, established and chaired the drug safety governance / Safety Advisory Committee for multiple organizations, served on the global teams who developed the REMS-RiskMAP-RMP programs for various products, some of these having played a key role in optimizing the benefit-risk profile, and was part of the teams that worked on optimizing the Adverse Events of Special Interest (AESI) and/or Standard Queries for various organizations.

On the PV compliance side, Cristina set up the GVP compliance and inspection & audit readiness programs at various companies, in collaboration with QA leadership and executive management, gap assessments and data quality programs, and participated in multiple audits & inspections with minimal/no findings.

She is a frequent speaker at PV & RM conferences and has authored various articles and a book chapter on pharmacovigilance topics.