Drug safety

Jennifer Song

*********@*****.***

OBJECTIVE A position in a compliance driven organization that will give me the opportunity to use my proven process and communication skills while furthering my personal development.

TECHNICAL SKILLS ARISg, RSGT, Oracle AERS, SharePoint, Great, Argus, Clintrace, Documentum, MS Office (Word, Excel, Outlook, PowerPoint), HTML graphics

EXPERIENCE

Bayer Healthcare Pharmaceuticals Wayne, NJ

Aerotek September 2010 – May 2011

Safety Data Associate

Perform daily and weekly reconciliation of all legal adverse events medical records routed to Case processing for Data entry.

Multiple supporting roles for functional groups to maintain business time lines.

Ensure accurate tracking details of various records received and routed.

Pdf, upload, and distribute all extracted adverse events to case processing.

Triage incoming legal adverse event medical records and assign to medical records extractors.

Manage and maintain metrics for all therapeutic areas.

Liaison between medical extractors and case processors for timely error resolution.

Mentor and train fellow colleagues on proper methods of data entry of adverse events

Help maintain team compliance to FDA time line.

Accessed and Dispensed local and central ARGUS data to Medical Extractor Team

Schering-Plough Research Institute Springfield, NJ

The Judge Group April 2009 – September 2010

Case Distribution Generalist II

Submit initial and follow-up expedited reports and associated document within required time frames for submission to the FDA.

Identify, prepare, and submit SUSAR cases that require Investigator Notification.

Run daily queries for action item within GPV Cares

Generate serial numbers with in the Great system for cases requiring Investigator notifications.

Provide weekly and monthly metrics for all cases processed and tasks performed.

Upload cases in the SharePoint system for electronic submissions.

Assist in the FDA inspection.

Create a PDF version for SUSAR cases and e-mail electronic version to applicable S-P operating units

Receive and process requests for nullification, downgrade, and deletions of cases from database, and coordinate with Country Operations

Provide assistance to Pharmacovigilance physicians and colleagues pertaining to case and reportability issues.

Update all reportability and submission tracking blocks with latest information from physicians and GPV team.

Prepare all periodic and annual aggregate reports for submission and distribution.

Corepharma Middlesex, NJ

The Judge Group December 2008 – April 2009

Regulatory associate

Process and Register all product complaints and Adverse events

Compose FDA 3500A forms for all adverse events.

Narrative writing for serious and non serious adverse events

Assist in filing all ANDA’s and IND’s

Report all necessary serious and non serious adverse events to the FDA

Generate and distribute periodic and annual adverse event reports to the FDA

Scan and maintain all electronic files of all ANDA’s, IND’s and Biostudies.

Documentation management of all paper and electronic files

Pfizer Inc., Safety and Risk Management Manhattan, NY

Technical Associate July 2006 – November 2008

Atrium Staffing (Contractor) Bridgewater, NJ

Site Case Coordinator July 2005 – July 2006

Ensure the integrity and consistency of adverse event reports by identifying issues and coordinating with colleagues to address them

Collaborated with Safety Surveillance Associates and physicians to troubleshoot data entry issues and inconsistent AE information within mandatory deadlines

Triage and allocate unassigned cases, including those associated with product complaints

Compose and integrate updates to the workflow database (RSGT) reference guide, standard operating procedures and training manuals

Generate and distribute bi-weekly reports to current Suppliers for PCO performance review reports.

Communicate with PCO’s (suppliers) in order to mend all queries (Inconsistencies)

Monitor and review regulatory documents (Cioms, AEM forms) to ensure consistency.

Perform quality checks and initially assess cases from suppliers sent to DSS.

Support electronic submissions for health authorities and licensing partners worldwide.

Identify and track case submissions for the FDA.

Communicate directly with PCO’s, License parties and various sources of safety reports regarding report submissions.

Provide subject matter expertise to process improvement initiatives.

Utilize expertise in safety systems to investigate status of reports and perform searches in databases for reconciliation purposes.

Ensure proper coding of events and drugs in safety reports to ensure correct routing to relevant Therapeutic Area Teams and Licensing Groups.

Interact with the Therapeutic Area Teams, Quality Safety Alliances and other functional groups to ensure adherence to processes and procedures.

Represent the ‘case receipt’ function during audits and inspections.

Perform UAT testing and verification.

Provide assistance to physicians and colleagues pertaining to case and reportability issues.

Process and register adverse events into FDA-regulated databases, e.g. eAEM, ARISg and RSGT

Ad hoc assistance to login of case items across sites as business needs demand

EDUCATION Kaplan University 6/2008 - Present

Bachelors of Science – Health Sciences

Healthcare Provider Certification 2008

BCLS: Adult CPR, Child CPR and Infant CPR. Blood-borne Pathogens

Cognitive A.E.D Training

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