jennifer parise

pharmacovigilance manager

About

Pharmacovigilance Manager EU-QPPV (Qualified Person Responsible for Pharmacovigilance)

Country

italy

City

rome

Industry

pharmaceuticals

Skill

pharmacovigilance, regulatory affairs, pharmacoepidemiology, english, powerpoint, safety risk managment, eudravigilance, good pharmacovigilance practices, biochimica, microsoft office, microsoft excel, clinical pharmacology, lavoro di squadra, auditing, music, biotecnologia, molecular biology, biologia molecolare, espanol, cell biology, biochemistry, lingua inglese

Experience

pharmacovigilance manager

di renzo regulatory affairs

2017-4 - Present · 9 yrs 6 mos

trainee, medical device department

di renzo regulatory affairs

2015-1 - 2015-2 · 2 mos

MDs registration on the Italian database NSIS

drug safety officer

di renzo regulatory affairs

2015-2 - 2017-4 · 2 yrs 3 mos

* Italian Pharmacovigilance Network daily check. * Spontaneous and literature reports submission to the Italian Health Authority. * Case triage of ICSRs via electronic (E2b) and non-electronic sources. * Management and request of Follow-Up. * Data entry into the Client Companies (CCs) Safety Database (ARISg; Clintrace; Safety Drug database). * Ensuring compliance and quality control of the case reports loaded into the Client Companies (CCs) Safety Database (ARISg; Clintrace; Safety Drug database). * CIOMS-I creation, reporting to partner and affiliates. * Reports generation in Safety Drug database (line listing, summary tabulation, CIOMS-I Form). * Worldwide and local identification of scientific literature case reports/clinical studies published on scientific journals for active substance. * Products registration, update, nullification on EVWEB-Eudravigilance(XEVMPD) as required by Article 57. * PSUR preparation and PSUR ( Periodic Safety Update Report) repository. * Preparation of Risk Management Plans (RMPs). * Pharmacovigilance System Master File (PSMF) update.