Experience

Sanofi-Aventis U.S. LLC
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Sample Operations Quality and Continuous Improvement

  • Oct 2012 - Present


Pfizer

• Events Services
• 1 - 100 Employee

• Director, PDMA Compliance

  • Oct 2010 - Oct 2012

  PDMA Compliance and Distribution, Starter Operations  Rendered proactive direction and assistance to multichannel platform as well as to external and internal customers in all aspects of compliance encompassing federal and state regulations for both legend drugs and controlled substances. Oversaw the compliance trending and tracking for drug sampling, as well as identification of state credential requirements for sampling controlled substances and legend drugs through state laws and regulations review. Monitored and analyzed data from PDMA inspections for pharmaceutical companies conducted during 2000–2010 and PDMA violations issued to serve as reference in developing compliance initiatives. Provided prompt resolutions to compliance issues and complexities through comprehensive analysis and investigation. Performed state requirements review for all alternative sampling mechanisms comprised of savings cards, Co-pay Cards, and vouchers. Managed and examined state sampling business rules to ensure drug sampling PDMA compliance. Maintained accuracy and completeness of all state reports for new regulations in New Hampshire. Led various audit programs such as physician signature audits, Michigan transactions audits, and field audits. Assured precise presentation, as well as approval of Review Committee (RC) of all documents in collaboration with Product Brand teams and legal counsel. Made sure that departmental standard operating procedures were up-to-date; deliver necessary training to staff. Show less

• Senior Manager, PDMA Compliance

  • Jun 2001 - Sep 2010

  PDMA Compliance and Distribution, Starter Operations, New York Office  Played an active role as lead compliance team member, responsible for monitoring the sales force activity to ensure close monitoring of all drug samples.  Reported missing drug samples to FDA and appropriate state agencies and provided guidance to senior sales management. Capitalized on industry expertise in restructuring processes, as well as in developing best practices in making necessary changes to the internal drug sample tracking system (StarTrak). Led efforts in assuring strict conformity of sales force with FDA’s established guidelines, as well as Pfizer’s policies and procedures for drug sample accountability. Served as PDMA compliance team lead on the internal FDA Inspection Readiness Team, in charge of meeting federal and state requirements. Performed in-depth analysis and investigation to resolve compliance issues, as well as potential issues and discrepancies. Worked in partnership with other stakeholders in automating the starter signature capturing process from paper to electronic signature. Designed, tested, and executed incidents reporting module (StarTrak) with shipment and non-shipment tracking and notification functionality in collaboration with other stakeholders. Utilized an e-mail generator with appropriate level of management notification; built-in follow-up alerts; and quick view of past audits conducted in enabling the electronic review of physician responses and internal notification. Conceptualized the design of physician signature audit module (StarTrak) with internal randomization process. Assumed full responsibility in assuring that all drug sample transactions were completed and retrievable upon request from the FDA. Managed and coordinated the annual update of internal PDMA compliance manual for Sales Force consumption. Show less

• Business and Customer Service Analyst

  • Jun 1999 - May 2001

  *Primary contact and liaison with the outsourced PeopleSoft Help Desk.*Ensured accuracy of employees’ current and historical information in the PeopleSoft Human Resources database: troubleshooting, investigated and resolved data issues, discrepancies and monitoring reports.*Interacted with Human Resource Management, PeopleSoft developers, programmers and system experts.*Provided consulting services to PeopleSoft end users for problem resolution. *Ensured accuracy of data consolidation for multiple Social Security Number cases.*Made recommendations to improve the database when appropriate and to highlight tracking issues. Show less