Experience

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  Parexel

  Jul 2008 - now

  • Contributing to Pharmacovigilance and Risk Management planning for the designated product by preparation of a comprehensive safety surveillance strategy• Accountable for all safety related aspects of the product, including aggregate reporting, signal detection and signal detection plan, risk management plan and comparative benefit risk• Leading the preparation and maintenance of Risk Management Plans and safety sections of labels• Preparing and reviewing periodic safety reports (e.g., PBRER, DSUR) in accordance with regulatory requirements• Carrying out signal detection activities and evaluation, and assessment of signals• Responding to safety requests for the assigned product from regulatory agencies or internal functions• Responsible for safety related study protocols updates, as well as the safety components of the briefing package (for filing activities)• Allocating tasks/reports to the team members according to individual capabilities • Providing guidance to team members on Pharmacovigilance activities• Implementing strategies for operational management and development in order to meet agreed organizational performance plans• Liaising regularly with client contacts to ensure that the quality and timeliness of the work is upheld• Mentoring new scientists/physicians, as well as scheduling and conducting trainings. Show less

  • Associate Director

    Nov 2018 - now

  • Senior Manager, Drug Safety Physician

    Jul 2008 - now