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associate director pharmacovigilance and risk management resume example with 14 years of experience

JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary
Accomplished pharmaceutical and healthcare professional with experience of the entire process of drug discovery, development and license maintenance. Expertise in Clinical Operations, Data Management, Pharmacovigilance and REMS (Risk Evaluation and Mitigation Strategies) Operational expertise includes people management, project management, process improvements, R&D strategy, business analysis, asset acquisition, data standards, KPI quality metrics.
Skills
  • Health Authority interactions and inspections
  • Staff mentoring, training and development
  • Database development, data analysis and interpretation
  • Data standardization
  • Design, implementation, operation and assessment of single and shared REMS programs
  • Cross-company collaborations
  • Surveillance/epidemiology programs
Work History
11/2009 to Current Associate Director, Pharmacovigilance and Risk Management Endo Pharmaceuticals | City, STATE,

Responsibility for risk management plans for Endo's pharmaceutical (branded and generic) products.

  • Interim Head of Risk Management.
  • Responsibility for risk management plans for Endo's and Par pharmaceutical (branded and generic) products.  Including single REMS and multi-company shared REMS Programs
  • Currently responsible for 19 REMS programs (approved and in various stages of development)
  • Authored multiple REMS assessments reports for various products
  • Supervise an epidemiology program designed to evaluate abuse-deterrent properties of an opioid product.         
  • Participated in two FDA inspections focused on REMS Programs with no findings. 
  • Participated in three FDA Advisory Committee meetings.

Associate Director, Clinical Operations and BioMetrics,November 2012 to February 2015

Sr. Clinical Data Manager                                      December 2009- November 2012 Responsible for developing and executing clinical operations and data management strategy to meet business goals and objectives.

  • Completed an assignment as interim head (eight months) of Clinical Operations and Biometrics during departmental reorganization.
  • Responsible for delivery of study deliverables that meet and exceed established quality, schedule and budget expectations.
  • Participated in three mock FDA inspections for NDA products under regulatory review.
  • Responsible to ensure appropriate resources and priorities are maintained for all projects.

10/2012 to 01/2015 Associate Director, Clinical Operations and BioMetrics Endo Pharmaceuticals | City, STATE,

Sr. Clinical Data Manager December 2009- November 2012

  • Responsible for developing and executing clinical operations and data management strategy to meet business goals and objectives. 
  • Completed an assignment as interim head (eight months) of Clinical Operations and Biometrics during departmental reorganization.
  • Responsible for delivery of study deliverables that meet and exceed established quality, schedule and budget expectations.
  • Participated in three mock FDA inspections for NDA products under regulatory review.
  • Responsible to ensure appropriate resources and priorities are maintained for all projects.
  • Created and implemented Clinical Data Standards



05/2006 to 11/2009 Manager, Data Management Leader Johnson And Johnson | City, STATE,

Sr. Clinical Data Manager March 2005 - June 2006

Clinical Data Coordinator March 2002 - March 2005

Clinical Data Assistant September 2000 - March 2002

Clinical Data Reviewer July 1999 - September 2000

Personnel activities:  

  • Interview and makes hiring decisions regarding direct reports
  • Ensure appropriate coaching and training
  • Execute Performance and Development Management activities
  • Make recommendations for compensation and promotion plans
  • Assist in coaching Clinical Data Management Specialists into Data Management Leader or Functional Leader positions

Project Allocation activities:

  • Routinely assess resource demand and allocation across and within projects and adjusts as appropriate
  • Determine best resource allocation of individuals based on their skills and career development
  • Raise resource issues to Center of Excellence Head and offer solutions  
  • Process activities, as appropriate
  • Serve as a Business Owner for one or more processes
  • Serve as a change champion for department
04/1997 to 06/2000 Registered Nurse/ Study Coordinator Chester County Allergy And Immunology Center | City, STATE, July 1999 – July 2000   - Worked part-time while employed J&J
Education
Expected in 1997 Master of Science | Nursing University of Delaware, Newark, DE GPA:

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Resume Overview

School Attended

  • University of Delaware

Job Titles Held:

  • Associate Director, Pharmacovigilance and Risk Management
  • Associate Director, Clinical Operations and BioMetrics
  • Manager, Data Management Leader
  • Registered Nurse/ Study Coordinator

Degrees

  • Master of Science

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