Drug Safety Case Manager

• Jul 2017 - Present

Senior PV Associate

• Jan 2016 - Present

-Performed triage and assessment for reportability of received safety information.- Use of IRT (Inbound Case Receipt and Triage) to enter and triage newly-arrived safety items.-Completion of case data entry, including narrative writing.-Performed appropriate case follow-up, including generation of follow-up requests.-Performed quality review of information entered into the drug safety database (Argus) and trained / mentored junior members of the team in case processing activities to ensure quality standards are maintained.- CAPA writing and effectiveness assessment.- Daily data entry and submission of reports via EVWEB.- Performed registration with Eudravigilance for electronic reporting on behalf of sponsor.

Pharmacovigilance scientist

• Mar 2015 - Dec 2015

- Responsible for submission of ICSRs (via OST) to EudraVigilance according to European legislation and guidelines.- Collaboration with PV Informatics regarding E2B failures to maintain quality and compliance of expedited submission.- Proactively identified areas of potential case processing inconsistency and worked with appropriate stakeholders to define tactics to remediate and drive quality.- Assisted in performing User Acceptance Testing (UAT) as required, in support of system changes that impact business process.

PHARMACOVIGILANCE ASSOCIATE

• Oct 2009 - Jul 2014

- Basic Case processing and narrative writing experience- Responsible for monitoring and correcting pending and rejected E2B reports for timely resubmission to the European and national Health Authorities and daily support to Novartis affiliates in any E2B transmission problem.- Quality check of safety data entered/loaded in Argus database.- Planned and coordinated E2B (submission and receive) deployment of ICSRs (electronic submission) to/from European Agencies and license partners for Novartis (global coordinator).- Provided appropriate training to the Novartis affiliates on Argus Safety database and E2B submission/receive functionalities (certified internal Novartis trainer).- Review of SOPs and Low Level Workflow Procedures related to E2Bs processes.- Review of draft European pharmacovigilance legislation and provided comments to EMA.- Involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals (e.g. Manual of Argus Processing).- Took part in several Novartis initiatives (E2B taskforce, E2B R3 implementation group etc) as E2B subject matter expert.- Sharepoint administrator for all sites and sub sites within the Drug Safety and Epidemiology department.- Contributed in writing PSUR subsections.- Performed literature review.

PHARMACOVIGILANCE TRAINEE

• Mar 2009 - Jul 2009

- 5-months traineeship at EMA in the Eudravigilance group.- Eudravigilance, EVWEB and MedDRA coding training received.- Creation of a structured database of Adverse Drug Reactions listed in the Summary of Product Characteristics of Centrally-Authorised Products (SPCs) and tested its use in validation of signal detection.- MedDRA coding of Adverse Drug Reactions listed in the SPCs - 5-months traineeship at EMA in the Eudravigilance group.- Eudravigilance, EVWEB and MedDRA coding training received.- Creation of a structured database of Adverse Drug Reactions listed in the Summary of Product Characteristics of Centrally-Authorised Products (SPCs) and tested its use in validation of signal detection.- MedDRA coding of Adverse Drug Reactions listed in the SPCs

DATA MANAGEMENT ASSISTANT

• Mar 2008 - Feb 2009

- Use of InForm and CTS clinical databases.- Identified errors and inconsistencies in CRF data and ensuring their resolution in order that databases can be declared clean and locked according to ICH GCP standards.- Accurately keyed data into Clinical Trial System.- Verified keyed data to ensure accuracy by conducting independent proof reading.- Raised data queries relating to logical inconsistencies within the data and referred to monitor / Clinical Data Coordinator as appropriate

CONTRACTOR within the Biology department

• Jun 2007 - Dec 2007

- Gene expression analysis with real-time PCR for laser captured samples.- Set up and used Axiovision for Laser Capture Microdissection. - Gene expression analysis with real-time PCR for laser captured samples.- Set up and used Axiovision for Laser Capture Microdissection.

Internship Cellular Signalling Laboratory

• 2006 - 2007

Internship

• 2003 - 2004