Experience

Acadia Pharmaceuticals Inc.

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Director, Drug Safety PV Ops

  • Mar 2018 - Present

   Oversight and management of PV Operations service provider responsible for performing collection, processing, and reporting of ICSRs, including associated quality and training activities to ensure regulatory timelines and global standards are met  Support the signal management process through workflow closure, ensuring that signals are tracked, and recommended actions are completed in a timely manner  Apply safety concepts (FDA, ICH, other international guidelines) to daily… Show more  Oversight and management of PV Operations service provider responsible for performing collection, processing, and reporting of ICSRs, including associated quality and training activities to ensure regulatory timelines and global standards are met  Support the signal management process through workflow closure, ensuring that signals are tracked, and recommended actions are completed in a timely manner  Apply safety concepts (FDA, ICH, other international guidelines) to daily functions  Participate in inspection readiness activities and preparation as needed  Participate in reconciliation procedures  Liase with medical, clinical, data management and regulatory personnel regarding safety issues, as appropriate.  Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review  Assist in accomplishing department and corporate objectives  Participate in cross-functional project teams; communicate across organizational levels and functions

• Associate Director,Drug Safety and Pharmacovigilance

  • Jan 2015 - Mar 2018

  Support department in all phases of drug safety operations to assure compliance with appropriate domestic and international regulations, as applicable.  Lead safety operations support for the Schizophrenia program including SAE reconciliation in conjunction with data management  Support the PADER generation  Hire and manage two direct reports, one full time employee and one contractor  Advisory Committee core team participant  Manage the implementation of the safety… Show more Support department in all phases of drug safety operations to assure compliance with appropriate domestic and international regulations, as applicable.  Lead safety operations support for the Schizophrenia program including SAE reconciliation in conjunction with data management  Support the PADER generation  Hire and manage two direct reports, one full time employee and one contractor  Advisory Committee core team participant  Manage the implementation of the safety database and the call center for adverse event reporting  Lead for PV launch readiness plan including AE training of all employees and vendors  Work in partnership with medical monitor to provide support for safety sections of clinical documents, annual report (DSUR), and other documents as needed  Responsible for vendor selection, management and oversight  Establish and maintain policies and procedures for the department  Ensure timely submission of all reports to regulatory agencies  Collaborate effectively with the study teams, cross-functional team members, and external partners

• Sr. Manager, Drug Safety & Pharmacovigilance

  • May 2014 - Jan 2015

  Set up of operational drug safety and pharmacovigilance team  Review of all safety related documents, including, IB, protocols, ISS, DSUR, SOPs, and safety tables and listings  Perform AE, medical history and concomitant indication coding for ongoing studies  Responsible for QC of SAE reconciliation reports between clinical database and safety database in collaboration with data management and safety vendor  Work with regulatory to ensure timely submission of IND… Show more Set up of operational drug safety and pharmacovigilance team  Review of all safety related documents, including, IB, protocols, ISS, DSUR, SOPs, and safety tables and listings  Perform AE, medical history and concomitant indication coding for ongoing studies  Responsible for QC of SAE reconciliation reports between clinical database and safety database in collaboration with data management and safety vendor  Work with regulatory to ensure timely submission of IND reports  Ensure timely authoring of reports (Annual Reports, PSUR, expedited reports) to regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA are responded to in a timely manner  Generate comprehensive, concise, and accurate narratives for all cases within the scope of responsibility



Santarus Inc.

• Manager, Drug Safety and Pharmacovigilance

  • Jan 2012 - Mar 2014

• Sr. Drug Safety Associate

  • Jun 2009 - Jan 2012



Santarus, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Drug Safety Associate

  • Jun 2006 - Jun 2009



Chugai Pharma

• Drug Safety Specialist II

  • 2004 - 2006