Safety Support
Resume:
Esther T. Sengulay
Apt.102
Washington, DC 20003
ac17b8@r.postjobfree.com
Cell: 848-***-****
Home: 202-***-****
SKILLS
Microsoft Office Suite: Word 2003, Excel 2003, Access, PowerPoint 2003) RSGT, MS Outlook 2010, MATS (Management and Tracking System), Lotus Notes, Netscape Navigator, ARISg 3.1.4, RSGT via Citrix, Argus Safety web v4.2SP1 0 HF2, Argus Safety Web v4.2SP1 HF6, Argus Safety Web v4.2SP1 HF14, Omni-Preserve, eAEM, DIDE2, Internet Explorer, Adobe Acrobat 6.0, Adobe Acrobat 9.2 professonal, Argus Safety Web v7.6., Ariba SAP(Staples) Navigate Network Printer/Cartridges
SUMMARY OF QUALIFICATIONS
Demonstrate the ability to work independently with or without supervision
Demonstrate the ability to supervising, delegating, produce, and multitasking
Demonstrate flexibility and ability to work with more or less number of people. Ability to provide unlimited support during high-pressure, and volume
Knowledgeable of relevant global safety regulations and guidelines. Experienced with quality or compliance operations and activities relating to safety reporting
Ability to setup computer and troubleshoot computer
Demonstrate ability to plug and play with computer, and high speed network printers
Knowledgeable of flat bed network scanners
Knowledgeable of Ariba SAP (staples)
EXPERIENCE
2010 to 10/ 2016 Pfizer Inc., Peapack, NJ
Senior Drug Safety Assistant
•Interact with therapeutic teams to customize standard letters as necessary
•Contribute to assessment of the timeliness of US follow-up letter request distributions against applicable guidelines and procedures
•Archiving of adverse event source documents as needed, DSS Outbound queries and Follow Up Letter correspondence
•Quality assurance of legacy case file order for DSS source documents of individual case safety reports
•Assure accuracy of tracking of archiving of adverse event report
•Administer inter-departmental problem-solving tactics, reconciling discrepancies daily and provide support to physicians, follow-up personnel and custodians
•As records specialist responsible for retrieving litigation and normal business audit request from off-site storage
•Responsible for Individual case study report (ICSR) indexed to a file share drive. Responsible for Archival of FDA 15-Day reports
•Responsible for printing and mailing follow-up letter to Health Care Professionals, Consumers and letter to other company via faxing or sending via email address, converting word documents into PDF
•As records specialist lead /organized and supervised individual case study report (ICSR) files to off-site 65000 case files April 2010 – July 31, 2010
•As records specialist responsible for coordinating and shipping ICSR to off-site every three months
• Download mixed media and paper into PDF to a shared drive for legal tracking purposes
• Scanned source documents into PDF, coping, faxing, and sent via email address both domestic and international
• Created Barcode and labels boxes that are ready to be shipped
• Indexed and Filed mixed media and paper (ICSR) into a secure Archive Room
2005-2009 Pfizer Inc., Bridgewater, NJ
Worldwide Safety Technical Associate
•Responsible for the maintenance and tracking of all World Wide Safety (WWS) Adverse Event archives, Bridgewater location
•Work through with EMEA (2005)
•Neurontin Litigation Project 2003 and 2009
•Celebrex, Bextra Litigation Project March of 2005, TNT Blank Company Causality 2005 Project
•Neuronton Project 2006
•PowderMed UK Project May 2008, J & J Litigation September 2008
•Sentrx & Encysive Project February 2009
•Support cross training and information sharing, Support inspection, audit and quality review initiatives as needed, Support development and maintenance of procedures and documentation supportive of applicable processes and functions
•Support promotion of proactive management of compliance relative to US follow-up letter requests, Support inspection, audit and quality review initiatives as needed, Support cross training and information sharing
•Download mixed media and paper into PDF to a shared drive for legal tracking purposes
•Scanned source documents into PDF, coping, faxing, and sending via email both international and domestic documentation
•Indexed and Filed all mixed media and paper (ICSR) into a secure Archive Room
•Created Barcode and labels for ICSR folders and for boxes that are ready to be shipped
•Support development and maintenance of procedures and documentation supportive of applicable processes and functions
•Indexing and filing of all individual case study record file into a secure Archive Room
2003-2004 Pfizer Inc., Morris Plains, NJ
Worldwide Safety Files Administrator
•Responsible for the maintenance and tracking of all World Wide Safety (WWS) Adverse Event archives, Morris Plains location
•WWS Files and US Follow-Up Letter/Record Retention and Archives responsibilities
•Reconciling a total of 30 boxes of ICSR Neurontin Litigation transition from New York, to Morris Plains, NJ
•Scanning ICSR into RSGT
•Creating Barcode and labels
•Indexing and filing of all ICSR into a secure Archive Room
03/2003–10/2006 Park Place Center Monmouth Junction, NJ
Patient Care Specialist-Sub Acute Unit
•Provide general healthcare assistance for seniors under nurse supervision
•Document patient information using office computer system and log book
•Increased productivity through superior patient interaction and prior department experience, allowing staff to evaluate more patients with higher quality
•Assist with physical excise
05/2000–06/2002 Crown Relocations Keasbey, NJ
File Administrator
•Database management including updating in house client information and warehouse files
•Event and training coordination: guest reservations, party arrangements and car rentals for visiting employees
•Administrative duties including: brochure and voucher preparation, employee timesheet distribution & collecting,
•Handling all incoming mailing and distributing mail
•Ensure filing of all documents received on a daily basis
•Received incoming phone calls for New Jersey and New York office
•Changed computer back-up system every week
•Mail sent via Federal Express mail, DHL, and or US postal service
•Opening documents, stamping, Scanning, coping, faxing
11-199*-**-**** Jewish Home For The Aged Somerset, NJ
Patient Care Specialist
•Provide general healthcare assistance for seniors under nurse supervision
•Ensure that assigned patients are nicely groomed and feed at all times with Kosher meal
•Document patient information using log book
•Ensure that they are actively involved in recreational activities
•Accompanied patients to the mall and or movies
•Increased productivity through superior patient interaction and prior department experience, allowing staff to evaluate more patients with higher quality
•Walking around with patience when climate is beautiful
•Interact with patient family and friends
09-1992-1999 Cedar Oaks Care Center
Patient Care Specialist
•Provide general healthcare assistance for seniors under nurse supervision
•Ensure that assigned patients are nicely groomed and feed at all times
•Document patient information using log book
•Ensure that they are actively involved in recreational activities
•Accompanied patients to the mall and or movies
•Increased productivity through superior patient interaction and prior department experience, allowing staff to evaluate more patients with higher quality
EDUCATION
1999-2000 Katharine Gibbs Piscataway, NJ
Legal Secretary
1993-1994 Middlesex County College Edison, NJ
Business Administration
07-1992 Young Women Christian Association Sierra Leone West African
Secondary School Equivalent
PROFESSIONAL CERTIFICATION Dates obtain Institution
Administrative Leadership Series 1- 3 06-09-2008 Holt Corporate Education, NY
Situational Self Leadership 06-2007 Holt Corporate Education, NY
Medical Terminology 08-2006 Holt Corporate Education, NY
Legal Secretary 06-2000 Katherine Gibbs School, NJ
Certified Nursing Assistant (CNA) 03-1993 Somerset, NJ
Certified Home Health Aide (CHHA) 1997 Freehold, NJ
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