Sara Geronazzo
Regulatory Affairs Officer at MORGAN PHARMA- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
Italiano Native or bilingual proficiency
-
Inglese -
Topline Score
Bio
Credentials
-
Clinical Research Associate CRES-Rome
-
Experience
-
MORGAN PHARMA
-
Italy
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Regulatory Affairs Officer
-
Oct 2019 - Present
Main duties:•managing DMF of some drugs in CTD or eCTD format;•submitting regulatory variations;•managing the drug traceability;•providing legalized certifications and documents for exporting and registering cosmetics, with Morgan’s brand or in a private label project;•liaising with competent authorities;•contribute to review artworks and drug advertising;•carrying out the notifications or changes about MDs (class I), cosmetics and dietary supplements;•importing MDs (Class I and IIa), IVD-MDs and PPE (Class III) from non-EU countries;•maintaining the company’s quality system (ISO 9001:2015 and ISO 13485:2016) and GDPR Register;•preparing documents for tender notice.
-
-
-
Eli Lilly and Company
-
United States
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Pharmacovigilance associate
-
Jun 2019 - Sep 2019
Main duties:•booking ADR and SAR to Lilly Safety System (LSS);•managing Follow-up and Action item;•screening literature;•doing reconciliations with Business alliance/TPO/QA department;•sending DSUR and SUSAR to AIFA and ERBs after filling-up the specific tracking tools;•doing the monthly quality checks.
-
-
Education
-
2018 - 2019
Università degli Studi di Verona
Pharmacovigilance and Regulatory Affairs -
2011 - 2016
Università degli Studi di Trieste
Doctor of Pharmacy - PharmD, Pharmacy -
2005 - 2010
Enrico Fermi High School
Industrial chemist, Chemist
Community
