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manager pharmacovigilance resume example with 20+ years of experience

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Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Summary
Enthusiastic Manager with seven years of experience in Pharmacovigilance and 20 years of experience in the pharmaceutical/biologics/medical device industries in pharmacovigilance, project management and clinical studies. A licensed pharmacist with a track record of maintaining positive relationships with both customers and staff, dedicated to providing the highest quality pharmacovigilance deliverables to both internal and external customers. 
Licenses
Licensed Pharmacist in Minnesota (1996 to current)
Drug Information Association Membership (1997 to current)
Project Management Institute Membership (2000 to 2010)
Skills
  • English:Strong writing and speaking skills (Native language)
  • German:Strong writing and speaking skills (High school year in Switzerland and semester at University in Germany)
  • Currently work with the Argus safety database
  • Familiar with the IRMS database
  • Experience working with Microsoft office programs including Word, Excel, Powerpoint, Visio and Project
Experience
11/2012 to Current Manager, Pharmacovigilance Computershare Inc | Minneapolis, MN,

My responsibilities: 3 years of authoring and contributing to numerous aggregate safety reports including PADERs, and PSURs as well as a variety of clinical safety documents including safety management plans and safety date for clinical reports; Supervise workflow of staff in the pharmacovigilance department for both post-marketing and clinical studies; Client interaction including addressing client questions and client notifications; Schedule and conduct Pharmacovigilance training for call center, medical information and pharmacovigilance staff; Participate in development and continuous improvement of processes and workflow including SOPs, task descriptions, narrative templates, coding and assessment conventions and job descriptions.

11/2011 to 10/2012 Pharmacovigilance Specialist I/II Merck & Co., Inc. | Idaho, ID,

My Responsibilities: Call intake for pharmaceutical, dietary supplement and medical device products for both adverse event and product complaint reporting; Pharmacovigilance case processing including: Case assessment; Case follow-up activities and MedWatch preparation; Developed training materials, conducted training presentations and on-the-job-training for pharmacovigilance staff; Worked on transition team for safety database transfer from AERS to Argus, also familiar with the IRMS database.

08/2010 to 11/2011 Drug Information Specialist/ Toxicologist Merck & Co., Inc. | Lawrence (Identigen), KS,

My Responsibilities: Managed health and safety calls, medical information requests and product complaints by either providing product information to consumers, end users and healthcare professionals or documenting their adverse event reports; Completely and accurately documented calls; Managed toxicology calls by providing consumers with safety information and treatment advice following exposure to products.

02/2009 to 08/2010 Sr. Project Manager Leidos Holdings Inc. | Springfield, VA,

My Responsibilities: ​Managed multiple cross-functional development team's budgets, timelines and deliverables including achieving regulatory approval of a number of pharmaceutical products.

11/2007 to 02/2009 Project Leader, Staff Scientist Abbott Laboratories | Bakersfield, CA,

My Responsibilities: Project leader for a drug-coated medical device development project; Coordinated manufacturing, testing and release activities for supplying the ongoing Phase II Clinical study of the device, including project plan creation, regular budget reviews, contingency planning and risk analysis.

08/2005 to 10/2007 Associate Director, Project Management PDL BioPharma | City, STATE,

My Responsibilities: Acted as Project Leader for a Phase II/III biological development product; Accountable for the timely completion of biologic manufacturing and testing activities (per GMP and GLP) required for release of the product for investigational use; Worked with the clinical and regulatory groups to coordinate manufacturing, packaging and shipping of clinical supplies and CMC documentation for regulatory approvals; Managed direct reports including annual reviews and performance appraisals.

02/2004 to 07/2005 Associate Director, Project Management Upsher-Smith Laboratories | City, STATE,

My Responsibilities: Managed project management personnel, activities and budgets to meet business goals and financial targets; Coordinated regular project updates for management, including progress and budget reports; Developed training materials and conducted training presentations for project management staff and project team members; Acted as a liaison between Business Development and Project Management in facilitating the initiation of new development projects; Conducted due diligence, contract development and strategic portfolio planning.

09/2000 to 02/2004 Project Manager Upsher-Smith Laboratories | City, STATE,

My Responsibilities: Managed multiple cross-functional development team's budgets, timelines and deliverables including achieving regulatory approval of a number of pharmaceutical products; Trained team members, project assistants and project leaders on project management basics, communication and PM tools.

08/1996 to 09/2000 Clinical Research Scientist Upsher-Smith Laboratories | City, STATE,

My Responsibilities: Monitored the conduct of clinical studies, Phase I and II, as required for FDA approval of pharmaceutical products; Initiated clinical study protocols and reviewed all study reports, safety management plans and contracts; Responsible for supplying all required clinical documentation for regulatory submission; Ensured that all clinical work was conducted according to GCPs; Served as a clinical representative on multiple cross-functional project teams charged with developing new pharmaceutical products.

Education and Training
Expected in 2006 to to Master of Business Administration | University of St. Thomas, Minneapolis, MN GPA:
Expected in 1996 to to Doctor of Pharmacy Degree | University of Minnesota College of Pharmacy, Minneapolis, MN GPA:
Expected in 1990 to to Bachelor of Arts Degree | St. Olaf College, Northfield, MN GPA:
Expected in 1988 to to | Studied German history, language and art University of Konstanz, Konstanz, GPA:
Expected in 1985 to to | High school year in Hausen bei Brugg Kantonschule Wettingen, Wettingen, GPA:
Community Service
Volunteer cook, Ronald McDonald House Charity, 2017
Team Leader, Twin Cities Heart Walk, 2016
Volunteer, Feed My Starving Children, 2015 & 2016
Sunday School Teacher, Zion Lutheran Church, 2004-2009
Confirmation Leader, Zion Lutheran Church, 2006-2007
Skills
Budget and contract development and monitoring; call center; client interaction; clinical study document creation; clinical study monitoring; continuous improvement of SOPs work instructions and conventions; due diligence; FDA meetings and communications; GMP; management of pharmacovigilance and project management personnel; MedDRA coding; presentations; project leader, project management tools; risk analysis; safety; study protocol development; strategic planning; training materials; workflow development.

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Resume Overview

School Attended

  • University of St. Thomas
  • University of Minnesota College of Pharmacy
  • St. Olaf College
  • University of Konstanz
  • Kantonschule Wettingen

Job Titles Held:

  • Manager, Pharmacovigilance
  • Pharmacovigilance Specialist I/II
  • Drug Information Specialist/ Toxicologist
  • Sr. Project Manager
  • Project Leader, Staff Scientist
  • Associate Director, Project Management
  • Associate Director, Project Management
  • Project Manager
  • Clinical Research Scientist

Degrees

  • Master of Business Administration
  • Doctor of Pharmacy Degree
  • Bachelor of Arts Degree

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