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Customer Service Safety

Hillsborough Township, NJ
October 11, 2018

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Cristobal Correa Jr.

**** ****** **.

Hillsborough, NJ. 08844

Mobile # 917-***-****



Records Coordinator/Receipt-Retention Specialist with over 20 years of pharmaceutical/corporate industry experience in the areas of legal, regulatory, drug safety & quality control, seeking a challenging position in any Company/Corporation industry, where I can utilize & share my strong project management, organizational, archivng and customer service skills.


Job-Coach/Mentor who strives on guiding and helping clients/students, with their developmental skills, in which shall prepare & contribute to them on becoming more proficient & increase their confidence to a higher level in which would assist to create the steps to an easy transitioning towards their quest for employment.


Job Assessment/Decision Making

Project Coordination & Management

Strong organizational and customer service skills

Excellent verbal and written communication skills

Proficiency with Microsoft Office, medical terminology

Ability to quickly learn and work with new technology and applications

Thorough, prompt and detail-oriented

Able to interact with senior management & collaborate with internal and

external clients in a professional and effective manner


Next-Fit Inc. 04/2016 – Present Boxing/Kick-Boxing/Self-Defense/Circuit/Interval Training

Instructor/ Group Sessions – 1 on 1 Sessions

Developed and Implemented 5 unique & diverse classes that incorporates the 4 types of exercises needed that targets the categories of: Endurance, Strength, Balance & flexibility, completing the total package & benefits in full.


2017- The Midland School

2016 - Job Coach/Part Time

Overseeing and mentoring the {clients/Students} on a daily basis and assisting on enhancing their developmental & motor skills, in which will increase their opportunity for job placement.

Trained in the “Danielle’s Law” and Positive Behavioral Supports

Prioritize on assisting clients/students on enhancing their currents skills.

Assess job/work duties assigned and evaluate their skill development progress.

Collaborate with teachers & staff members by working hand & hand to maintain

an open communication at all times.

Monitor, Evaluate & Document progress of clients & students.

Periodically administer & document required medication to clients/students Etc.


2014 - Garcia & Patni Associates, LLC (Scarsdale, NY)

2012 - Drug Safety Consultant [Contractor]

Major responsibilities included:

Preparing case narratives for spontaneous and clinical trial cases; summarizing all relevant medical information for the adverse event(s).

Performing data quality checks on key fields.

Assisting with the compilation and preparation of PADERs and GPSURs.

PHARMA EXPERIENCE – 17 year Tenure

2011 - Sanofi-Aventis, Inc. (Bridgewater, NJ)

1994 - Records Coordinator/Receipt-Retention, US Pharmacovigilance

Major responsibilities / accomplishments included:

Responsible for managing the US Pharmacovigilance (PV) file room, offsite archiving, and the timely and accurate filing and retrieval of AE cases.

Responsible for the initial screening, processing [case book-in] and forwarding of potential AE case information (Initial, Follow-up) received via all sources.

Responsible for the creation and distribution of Follow-Up Letters and Letters to Other Manufacturers within procedural and regulatory timelines.

Coordinated the implementation of a new Siebel database to monitor and track all incoming (potential) AE case information received via e-mail, fax, and postal mail.

Key member of a cross functional, US Pharmacovigilance and Information Technology (IT) team, responsible for the implementation of an electronic case file repository.

Actively participated in a number of key departmental teams and projects, including the FDA Audit Readiness Team and the USPV Process Improvement project.

Actively and successfully participated in 2 FDA audits:

oRetrieved ICSR case files (on and off site) in a timely manner

oExplained the Follow-Up Letters / Letters to Other Manufacturers tracking, preparation and distribution process.

Assisted in the compilation and generation of FDA and ICH periodic safety update reports (PADERs, GPSURs).

Provided Administrative and Data Entry support to the USPV team, as needed.

Assisted with report distribution activities (i.e. electronic (E2B) submission of expedited (US, ex-US) 7- and 15-Day Alert reports to the FDA via the worldwide safety database), as needed.

Prepared various procedural documents (SOPs, WPDs) and training manuals pertaining to USPV Record Retention, Archiving and Retrieval processes in accordance with all relevant ICH and FDA regulations and company procedures.

Responsible for the training, mentoring new Document Management employees [and contractors] on departmental processes and procedures

Implemented an automated system for tracking the processing of Follow-Up Letters and Letters to Other Manufacturers to ensure compliance with procedural and regulatory timelines.

Responsible for US Drug Safety office supplies and budget; ensuring costs were within specified (budgetary) requirements.

Responsible for the training of new Document Management employees and contractors on departmental processes and procedures.

Provided administrative support for US Drug Safety (e.g. organized and facilitated meetings, conferences, and other special events).

Maintained a limited access filing system to ensured document control.


1994 - Underwriting Clerk, Marine Department

1985 American International Underwriters

Major responsibilities / accomplishments included:

Supported the Marine Risk Management team in general marine liability claims related activities by compiling data and performing routine clerical tasks in order to relieve insurance underwriters of administrative details, using knowledge of underwriting and policy issuing procedures.

Prepared requisitions and reviewed reports and results of investigations to compile and summarized pertinent data onto underwriting worksheets and database.

oScanned documents; assisted in data entry; checked for risk-involved matters to eeeeeeeeeeeeeeeinsurance underwriter for evaluation.

Maintained related files.




2015 - RVCC – Currently enrolled on line (Summer Semester) Health Information

Technology: Associates of Applied Science


Rutgers/Job Coach Phases 1/2/3/4

GCP: ICH Good Clinical Practice

GMP: Documentation and Record Keeping

USA – Amateur/Boxing/Member/Coach

Nesta – Boxing/Kick-Boxing – Focus Pad Instructor

ASFA/American Sports & Fitness Association Self Defense Instructor

Red Cross/ CPR / First Aid and Safety Instructor (Adult, Child, and Infant)

American Safety & Health Institute – Blood Borne Pathogens


Computer / Software Skills:

ARISg™ Safety (drug safety and pharmacovigilance database)

Clintrace Safety (drug safety and pharmacovigilance database)

MedDRA (Medical Dictionary for Regulatory Activities) coding

WHO Drug Dictionary

Siebel Systems

EMC Documentum

Microsoft Windows

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Microsoft Access

Apple OS X

Adobe Acrobat

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