Medical Safety
Resume:
Josephine C Stratton
******.********@*****.***
Education:
West Chester University – MSN
Neumann College - BSN
PROFESSIONAL EXPERIENCE:
Endo Pharmaceuticals, Malvern PA 19355 AUG-2016 – JUL-2017
Drug Safety Triage Associate –Triage spontaneous and clinical study reports ready for processing
• Proficient with Argus database - Processed spontaneous, litigation and clinical trial reports
• Authored concise, safety narratives and prepared adverse event reports for medical review and submission to regulatory authorities
• Maintained tracking log for all adverse event reports. Request follow-up information concerning the AE reports as appropriate from consumers, and healthcare professionals
• Monitored the drug safety mailbox, fax and phone for incoming adverse event reports
• Triaged/analyzed adverse event information for entry into the adverse event tracking and reporting system
• Coded and classified adverse events reports according to MedDRA guidelines and departmental SOPs
• Supported the maintenance and enhancement of the company’s adverse event tracking and reporting system
• Developed a reconciliation process with Medical Information and Quality Assurance
• Developed a system for sending serious adverse event reports to other manufacturers
• Assisted clinical trial working groups with safety and data reconciliation
• Participated in data review and signal detection process
C3i Healthcare Connections, a Division of Telerx JAN-2015 – JUN-2016
Senior Safety Scientist
• Proficient with Argus database
• Case processed serious/non-serious spontaneous reports including medical records and clinical trial reports
• End of Line Quality review of all serious and non-serious cases processed by off shore vendors
• Provided internal training for all new drug safety associates
• Monitored daily case load to ensure compliance with regulatory submissions, to client and third party vendors
Office of Consumer Medical Safety/Johnson & Johnson 07/2014 – 12/2014 Senior Operations Performance Analyst (Oversight for Consumer products)
• Performed second level end of line quality review of all spontaneous and solicited Johnson & Johnson consumer cases on behalf of Partner Company to assure cases were processed accurately and completely
• Trained staff on safety case processing (post-marketing, clinical trials, literature, devices)
• Contact for projects regarding workflow, resolution of project issues and new training
• Updated SOPs, Guidance Document and job aides
• CAPA -evaluated for retrospective deletion of cases already submitted to Health authorities
• FDA audit request - investigated cases with late submissions
Global Medical Safety - Janssen 05/2012 – 06/2014
Senior Operations Performance (OP) Analyst, Compliance Standards & Alliances
• Implemented, monitored appropriate dashboard metrics for compliance, quality, productivity and cost-per-case for onshore, offshore and ad hoc vendor partners
• Conducted ICSR quality reviews on all JnJ products and agreed procedures
• Participated in functional and cross-functional project teams and meetings relating to operational performance analysis
• Performed root cause analysis of performance data
• Identified and implemented appropriate remediation activities
• Participated in internal audits and external inspections as identified
• Assisted in development & implementation of corrective/preventive action plans (CAPPs). Participate in local or global project teams, including on – time delivery of assigned responsibilities
Janssen Research & Development, LLC 6/2003 – 04/2010
Drug Safety Associate
• Provided safety information pertaining to all J&J products to internal and external customers on investigational, and post marketing products including medical devices - triage, process MDR reports per regulations
• Triaged, assessed and assigned regulatory status for all assigned products
• Monitored for current serious cases in workflow and ensure compliance with regulatory timelines
• Composed concise narratives, coded and assigned labeling for adverse events using MedDRA and entered in the ARISg safety database
• Reviewed cases in ARISg database in order to make corrections for data reconciliation
• Triaged, reviewed and processed reports for medical devices, legal cases, literature, clinical trials and post marketing
COMPLETED A 6-MONTH ROTATIONAL OPPORTUNITY IN PHARMACOVIGILANCE AGGREGATE REPORTING (PVAR)
• Developed knowledge of aggregate reporting and enhanced medical writing skills. Progressed through rotational development with responsibility for - Preparation and distribution of multiple Periodic Adverse Drug Experience Report (PADER) and Investigational New Drug (IND) reports
• Project management of PADER reports
• Participated in internal audits for Women’s Health products
Sanofi Synthelabo 06/2001 – 12/2002
Contract In-House CRA
• Assist with obtaining follow-up for Serious Adverse Events; track, process and complete Data Reconciliation Forms (DRFs)
• Coordinate with regional research associates to ensure compliance and adherence to trial protocol
Center for Arts and Technology (CAT) 1996 – 2001
Clinical Nursing Instructor
Supervised, directed and educated nursing students in various clinical settings
Delaware County Community College 1996 -2004
Adjunct Nursing Faculty
• Taught Medical Terminology course to Allied Health Students
Chester County Hospital 1991 – 2003
Medical, surgical, orthopedic, oncology, cardiac and infectious disease patient population
Leadership roles:
• Implemented cultural and product knowledge training in preparation for off shore product transfer
• Volunteered to travel abroad to provide product specific training for off shore vendor
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