Medical Advisor

• Mar 2022 - Present

Team Lead Medical Monitor

• Nov 2021 - Mar 2022

Senior Manager, Regional Safety Excellence, Australia & Asia - RMP Lead

• Oct 2019 - Nov 2021

-Responsible for all aspects of risk management plan (RMP) development, maintenance, and implementation for Alexion products in Australia, New Zealand, and designated countries in the APAC region. -Ensured a high standard of partner and third–party oversight of all RMP related activities, including the collection, review and evaluation of Key Performance Indicators (KPIs) for implementation of additional risk minimization measures and effectiveness checks. -Coordinated the safety-related aspects of the regional post-marketing safety surveillance studies including obtaining, formulating and reviewing data utilised in the compilation of these reports and ensuring regulatory commitments and reporting timelines were met. Show less

Drug Safety Physician, Manager

• Apr 2015 - Sep 2019

Safety scientist (global PV) for Roche, Basel. Responsible for carrying out pharmacovigilance and risk management activities for assigned products by: • Contributing to pharmacovigilance planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues • Supporting the preparation and maintenance of risk management plans and risk mitigation activities. • Preparing/ reviewing periodic safety reports (PSUR/PBRER, DSUR) in accordance with regulatory requirements. • Supporting the preparation and maintenance of safety sections of the drug labels. • Conducting/supporting signal detection, validation and evaluation, literature review. • Authoring and reviewing drug safety reports (issue work-ups), for signals and health authority requests. • Narrative and CSR review Show less

Drug Safety Physician, Lead

• Dec 2011 - Apr 2015

Performed routine signal detection for the product through review of line listings (mortality, SUR, special populations, off-label use, lack of efficacy), monthly literature and disproportionality alerts. Authored and performed medical review of narratives for inclusion in Clinical Study Reports - for medical cohesiveness. Medical review and query resolution for Individual Case Safety Report (ICSR) processing team. Performed routine signal detection for the product through review of line listings (mortality, SUR, special populations, off-label use, lack of efficacy), monthly literature and disproportionality alerts. Authored and performed medical review of narratives for inclusion in Clinical Study Reports - for medical cohesiveness. Medical review and query resolution for Individual Case Safety Report (ICSR) processing team.

Senior Resident/ Registrar, Dept of Medicine

• Jan 2010 - Dec 2011

Senior Medical Officer, Cardiac Care Unit

• Jul 2009 - Jan 2010

Resident Medical Officer

• Jun 2006 - May 2009

Resident medical officer

• Mar 2005 - Feb 2006