Sofia Antunes Email & Phone Number

• Open to a new challenge that can fulfill my professional ambitions and that I can still keep learning with co-workers and at the same time be able to share my knowledge with them. All, in order to level up the "Company.
• xEVMPD training course (updating/ongoing);
• Signal Management training;
• Global Pharmacovigilance Professional Certification - A… Show more Open to a new challenge that can fulfill my professional ambitions and that I can still keep learning with co-workers and at the same time be able to.
• Global Pharmacovigilance Professional Certification - A Limited-Time Pilot Program to Shape the Future of Certification;
• Emotional Intelligence and Intuitive Leadership training;

Portugal

1. Managing PV systems for clients EMA oriented and FDA oriented;2. PV audits (internal and external) performance and assistance;3. Weekly literature search (FDA and EMA oriented);4. ICSRs insertion/quality review in Safety Databases (i.e. Argus, SafetyDrugs)5. Periodic aggregate reports writting (i.e. PADER - FDA) and reviewing (PSUR. RMP - EMA);6. SOPs.

Lisboa E Região, Portugal

Implementation of Pharmacovigilance System for several Clients and Pharmacovigilance activities such as:For FDA:1. Aggregate reports writing, Quality Review;2. Cases data entry, Quality Review and cases submission to FDA (Through WebTrader or Gateway);3. weekly literature search (Embase, Pubmed);4. weekly and monthly reconciliations;5. MedDRA and WHO Drug.

Lisboa E Região, Portugal

EU QPPV, Local Safety contactActivities:- Management of PV Affairs area- Management of PV Quality System (PSMF, Audit, CAPA, Training, SOP, Inspection)- Comunication with CA inside and outside EU- PV Training- Interaction with Partners in various countries (EU, Middle East, Africa, Asia, Central and South America) on safety issues- SAE, SUSAR Management.

Pharmacovigilance Department and Scientific Affairs Department

Lisboa E Região, Portugal

Loures

Bonn, Alemanha

Loures

Loures

Nível C1

Mestrado, Ciências Farmacêuticas

Education record

Nível B1

Education record

Activities and Societies: Voleibol Andebol

Education record

Activities and Societies: Andebol