Experience

Kyowa Kirin Co., Ltd.

• Japan
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Global Labelling Lead Associate Director

  • Jul 2022 - Present



Freelance

• Remote

• Safety and Labelling Consultant

  • Sep 2021 - Jul 2022

  Leveraging many years labelling, regulatory, pharmacovigilance, signal detection and safety issue management experience and providing rational, cost-effective solutions. Leveraging many years labelling, regulatory, pharmacovigilance, signal detection and safety issue management experience and providing rational, cost-effective solutions.



Reckitt

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Global Safety Assurance Operations Manager at RB

  • Jan 2020 - Sep 2021

• Global Vigilance Coordination Manager

  • Mar 2018 - Jan 2020

• Global Consumer Labelling Manager Health

  • Oct 2016 - Feb 2018

• Senior Core Safety Writer

  • Jan 2013 - Sep 2017

  Responsible for documentation of global company reference safety information.Multiple MHRA audit experience, extensive EU regulatory authority interaction, RoW regulatory authority familiarity including BRIC, Australia, US, Japan, Middle East.Creation of efficient and consistent processes to implement licence and safety labelling harmonization globally.

• Senior Technical Systems Associate

  • Jan 2010 - Dec 2012

  Providing cross category technical healthcare support for Medical and Pharmacovigilance departments and personnel. Including document management systems support and development, change control process implementation and contract management for third party suppliers of medical and technical content.This role also involved a significant proportion of GxP issue management and troubleshooting of product issues.

• Medical Advisor

  • Jun 2007 - Dec 2009

  Responsible for medical NPD support and various licence management activities (clinical overviews and summaries for new applications, renewals, Switch P>GSL) for Gaviscon and Strepsils brands.



Pharmacovigilance Review

• Editor

  • 2013 - Sep 2021

  Industry awareness, sourcing articles for key issues. Industry awareness, sourcing articles for key issues.