Marina Damiano
Qa Ra Post Market Surveillance Specialist @Dedalus
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WORK HISTORY
Qa Ra Post Market Surveillance Specialist @Dedalus
Management of Post Market Surveillance, Vigilance and Quality Assurance activities for MD and IVD softwares.Post Market Surveillance- Providing and analysing post market surveillance data for PMS Plan, PMS Report (PMSR), Periodic Safety Update Report (PSUR), Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), and related reports- Lead cross-functional team members in collecting, analysing, trending and reporting safety and performance data to proactively identify potential safety risks.Vigilance- Management of complaints with clinical risk- Reporting activities (MIR submissions) and interactions with Health Authorities and Notified Bodies- Field Safety Corrective Actions management.Quality Assurance- Initiating effective Corrective and Preventive Actions; monitoring process and implementation effectiveness of CAPA and NC- Revision of Technical Quality Agreements (TQA) for distribution and supplier agreements.
EDUCATION
Università degli Studi di Napoli Federico II
Bachelor's degree, Pharmaceutical sciences
Università degli Studi di Napoli Federico II
Master's Degree, Pharmaceutical Biotechnology
ABOUT MARINA DAMIANO
QA/RA Post Market Surveillance Specialist presso Dedalus
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