Josephine C Stratton

484-***-****

ac2iut@r.postjobfree.com

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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