Sherry Ann Perez

Experience

• 

  Bayer Philippines, Inc

  Mar 1993 - Aug 1997

  Medical Representative
• 

  Bausch & Lomb Philippines, Inc

  Dec 1998 - May 2004

  • Manager, Regulatory Affairs & Marketing Services, Company Pharmacist

    Jan 2003 - May 2004

  • Regulatory Affairs Officer, Company Pharmacist

    Jun 1999 - Dec 2002

  • Regulatory Affairs Consultant, Company Pharmacist

    Dec 1998 - May 1999
• 

  Bausch + Lomb

  Oct 2004 - Dec 2013

  • Lead in creating and maintaining Company Core Data Sheet (CCDS) in close collaboration with CCDS Committee (comprise of global regulatory affairs, global safety & vigilance, pharmacovigilance, and medical reviewers).• Lead in writing and submitting postmarketing periodic safety reports and submission of ICSRs to the FDA. • Expert in generating adverse event line listings from safety database (ARISg) for aggregate reports and signal detection activities. • Quality reviewer of adverse event reports ensuring completeness, accuracy, and adherence prior to submission to regulatory authorities in accordance with current regulations governing the processing and reporting of safety data. • Pharmacovigilance reviewer of product labeling for pharmaceutical, OTC and nutritional products.• Assisted in vital improvement of departmental work instructions related to processing of aggregate reports (i.e. periodic safety reports, annual product reviews, and product quality review) • Provided valuable assistance in updating pharmacovigilance SOPs and conducting training of fellow safety specialists and new hires. • Assisted in validation activities for a new safety database (ARISg) and conducted related trainings to pharmacovigilance associates. Show less

  • Sr. Specialist Global Operations, Global Safety & Vigilance

    Mar 2012 - Dec 2013

  • Global Operations Specialist, Global Safety & Vigilance

    Jan 2011 - Feb 2012

  • Pharmacovigilance Specialist (US Postmarketing)

    Oct 2004 - Dec 2010
• 

  Bausch Health Companies Inc.

  Jan 2014 - Sept 2022

  • Aggregate reports writing such as periodic safety reports in close coordination with Pharmacovigilance, Risk Management, Regulatory Affairs, CMC, Medical Affairs, and Clinical Affairs.• Lead quality reviewer of Aggregate safety reports prepared by vendors/contractors. • Submission lead for postmarketing periodic safety reports (PADER,PSUR) in close collaboration with Regulatory Affairs• Lead in Aggregate reports planning and submission tracking.• Author of SOPs, work instructions and templates related to aggregate reports preparation and submission. • Provides training on aggregate reports and other pharmacovigilance related aspects. Show less

  • Sr. Manager Global Aggregate Reports Group, Global Pharmacovigilance & Risk Management

    Jul 2018 - Sept 2022

  • Sr. Manager, Global Pharmacovigilance & Risk Management

    Apr 2017 - Jul 2018

  • Manager, Global Pharmacovigilance & Risk Management

    Aug 2016 - Mar 2017

  • Sr. Specialist Global Aggregate Reports, Global Pharmacovigilance & Risk Management

    Jan 2014 - Aug 2016
• 

  Bausch + Lomb

  Sept 2022 - now

  Director Head of Global Aggregate Reports Group - Global Pharmacovigilance & Risk Management