Customer Service High School
Resume:
Dawn M. Finley
Piscataway, NJ 08854
**********@*****.***
Pharmaceutical Industry Knowledge
US Reporting Requirement for:
a) Domestic Periodic Events submitted to NDA
b) Domestic Expedited Events submitted to NDA
c) Foreign Expedited Events submitted to NDA
d) Domestic Clinical Events submitted to IND
e) Foreign Clinical Events submitted to IND
Various Phases and required Systems Development Life Cycle (SDLC) deliverables
Criteria for Serious Adverse Events
FDA 1572 Guidance for Sponsors, Clinical Investigators, and Institutional Review
Boards
Adverse Event Trending/Signaling
Labeling Changes
Knowledge of Oracle Ares software
Knowledge of ARGUS software
Objective: An interesting position with a growing company which allows me to utilize my extensive
knowledge and experience in the pharmaceutical industry. The desired position would
offer growth, training and an opportunity to further build a rewarding career upon my
solid foundation.
Experience: Schering Plough/Merck Rahway, NJ
Business Specialist/Technical Analyst Jan 2008 to Nov 2013
Author requirement specification documentation
Author Change Plan documentation
Author Change Summary documentation
Author User Acceptance Test scripts designed to verify to report functionality
Review and approve executed UAT scripts
Author Change Summary documentation
Manage the collection, and analysis of data for presentation of monthly metrics to
management team
Preparation of draft narrative data for aggregate reports for review CRM/Clinical Staff
prior to submission to regulatory and health authorities.
Generate line listings in support of aggregate reports.
Provide prompt and courteous customer service to Business unit health care professionals.
Actively participate in regularly scheduled process improvement meetings.
Write SQL Plus query scripts for report generation and data consistency checks assigning
user privileges.
Manage AECTS web based US local case tracking database; perform system administrator
functions including creating new user accounts; assigning user privileges, maintain/update
list of active and inactive users
Train colleagues to create user accounts, assign privileges, and perform data entry using
the AECTS web based US local case tracking database
Organon Inc./Schering Plough Springfield, NJ
Drug Safety Specialist Jul 2005 to Dec 2007
Generate weekly and monthly reports to facilitate the tracking of departmental metrics
and FDA compliance rating.
Author SQL Plus query scripts for report generation and data consistency checks
Perform root cause analysis on late cases
Suggested corrective and preventative action plans (CAPA)
Provide prompt and courteous customer service to Business unit health care professionals.
Write Performance Qualification Document for testing of new applications and software
updates
Create testing materials and perform testing for new applications
Assist in writing of SOPs
Train new Drug Safety Associates
Manage the collection, analysis and preparation of Implanon Insertion/Removal Related
Event (IRRE) data for quarterly submission to health authorities.
Generate and review periodic/aggregate reports listings for internal/external distribution
to Regulatory Affairs and various US and Foreign Health Authorities.
Generate draft narrative summarization/analysis of adverse event data collected for NDA
and IND submissions.
Review individual clinical and Post marketing events/cases to ensure reporting
requirements are being met
Organon Inc West Orange, NJ
Drug Safety Associate II Dec 2001 to Jun 2005
Write SQL Plus query scripts for report generation and data consistency checks
Produce AD HOC Reports upon request
Assist in design, maintenance and manipulation of aggregate reports for internal/external
distribution to Regulatory and various US/Foreign Health Authorities.
Maintain an Excel database of Active Investigators for Post marketing Studies
Reconcile Serious Adverse Events captured in the Global Clinical database with those
captured in the Global Pharmacovigilance database.
Submission of IND and NDA expedited reports to Regulatory and/or Study Investigators
Access Tracking database to facilitate the distribution of Investigator Alert letters
Perform monitoring of compliance, metrics and performance data
Provide assistance with investigations, corrective and preventive action including root
cause analysis of non compliant single case reports (late cases) and aggregate reports
Trained all new Drug Safety Associates
Organon Inc West Orange, NJ
Drug Safety Associate I/Clinical Safety Coord. Aug 1990 to Nov 2001
Perform visual quality check of outgoing work
Maintain a database of Active Investigator Sites, making addition and deletions upon notification
Perform Critical Variable Checks: Generate a listing from the Clintrial database and compare with
hard copy of Serious Adverse Event Form.
Screen design for all new studies using Clintrial version 3.3/Oracle System 7.1
Design Case Report Forms for all new studies using PerForm/PerFIll graphic software package
Education: West Side High School
1984
Skills: Outlook Custom
Access
Microsoft Office Suite
SQL
SpotFire Visualization Tool
Remedy Incident Management
Quality Center
MIDAS Document Management
Application Lifecycle Management
Documentum Sharepoint
Contact this candidate