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 new challenge". For that, I am improving my soft-skills and updating my PV knowledge.Some courses that, meanwhile, I took were:• 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 share my knowledge with them. All, in order to level up the "Company new challenge". For that, I am improving my soft-skills and updating my PV knowledge.Some courses that, meanwhile, I took were:• xEVMPD training course (updating/ongoing);• Signal Management training;• Global Pharmacovigilance Professional Certification - A Limited-Time Pilot Program to Shape the Future of Certification;• Emotional Intelligence and Intuitive Leadership training;• PV Labelling (EMA and FDA) training;• Minfulness training;• Managing Multi-Generational Teams Training;• Internal Audit- advanced level training;• PSMF traning from DIA;• Leardership and communicatin styles trainings;• Understanding Your Leadership Style training;• Managing Remote Workers training (ongoing);• Managing Change training (ongoing);• Leading Through Failure training;• Leading Through Collaborative Communication training;• Leading by Motivating Others training;• How to Make Good Decisions Quickly training;• How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality training (ongoing);• Delegating for results training. Show less

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 creation and review;7. SDEAs, PVA and PV Manual creation and review;8. Conducting meetings with clients and… Show more 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 creation and review;7. SDEAs, PVA and PV Manual creation and review;8. Conducting meetings with clients and writing meeting minutes;9. Problems solving and improvement of PV team performance solutions;10. KPI's identification and evaluatio11. Identify Deviations and handling CAPAs12. Signal Management (FDA and EMA oriented);13. Writting and reviewing different types of reconciliations with clients and their partner14. PV annual fees review for each client;15. Handling Educational Materials for European clients and Competent Authorities;16. PSMFs creation and maintenance;17. xEVMPD oversight;18. PV systems maintenance in order to be Inspection ready. Show less

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 codding;6. MedDRA and WHO Drug licenses controlling/managing;7. Signal detection reports;8. Working on… Show more 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 codding;6. MedDRA and WHO Drug licenses controlling/managing;7. Signal detection reports;8. Working on different safety databases, such as Argus, AB Cube - Safety Easy, Distiller;9. Working as a Team Leader and co-Team Leader for clients;10. As a Team Leader and co-Team Leader: managing the work flow and activities within the team;11. As a Team Leader and co-Team Leader: handling weekly meetings with the clients;12. As a Team Leader and co-Team Leader: managing the clients' inbox;13. As a Team Leader and co-Team Leader: Evaluate the KPI's for each client;14. Creation and review SOPs and WIs;15. Creation templates for narratives, reports, signal detection reports or other documents needed;16. Managing Business decisions document for different clients;17. working on a pipeline including: Medical devices, Auto-injectors, capsules, tablets, nasal-spray indifferent heath areas such as Migraines, Hormone therapy replacement, Rheumatoid Arthritis,treatment of the signs and symptoms of benign prostatic hyperplasia, treatment of CoronavirusDisease 2019 (COVID-19), urea cycle disorders, and others.18. Pharmacovigilance basics training to the company annually;19. Pharmacovigilance tasks training to new team members;20. Identify Deviations and handling CAPAsFrom Nov-2018 to Apr-2020 (extra job role):For EMA: Medical Information/Call center Back-up for European client. Working with IRMS platform to capture all the information received through calls. And handling medical questions from Health care professionals and parents regarding the client's product through call and email. Show less

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- Review and approval of: PSUR/PBRER, RMP, SOPs, SDEAs, Medical Literature, Safety Variations (NAP, MRP, DCP)… Show more 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- Review and approval of: PSUR/PBRER, RMP, SOPs, SDEAs, Medical Literature, Safety Variations (NAP, MRP, DCP), PASS/DUS Protocols- xEVMPD Maintenance- Signal Management and Risk Benefit Analysis- Management of Medical Devices Vigilance System and Food Suplements System- Management of outsourced services- Responsible PV docs for submission of new MA applications inside and outside of PT: United Kingdom, United Arab Emirates, Venezuela, Iran, Vietnam, Colombia, Canada, Saudi Arabia, Kuwait, Kosovo, Mozambique, Azerbaijan, othersMedical AffairsActivities:- Management of Medical Affairs Department- Provide scientific training for Sales force - Internal Collaboration (Mkt, Sales, R&D, Legal, BD, RA, HR, Board)- Support the launch of new products- Review and approval of Promotional Materials- Supporting marketing scientific input and expertise in the design and construction of promotional materials, new claims- Respond to unsolicited requests for scientific information with Medical Experts/HCP/Consumers- Development, review and approval of Educational Materials and Programs- Planning, execution and follow-up training for Sales and Medical Affairs staff in disease and product knowledge in collaboration with Marketing /Sales- Elaboration of Technical Reports & Medical Writing (Non-Clinical and Clinical Reports; Scientific papers;- Safety and Efficacy comparison reports between products) Show less

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