Medical Records Specialist / Safety Records Coordinator
Walter M. Sierra
407 Avenue A
Bayonne, NJ 07002
Bilingual professional with expertise in adverse event (AE) case records management. Ten years of experience in drug safety and surveillance (DSS), and aggregate reporting to the FDA. Coordinate Medical Review meetings, Fifteen years of experience in supervising employees. Background in implementing training programs, developing electronic case tracking systems, performing QA & QC, and managing vendors.
Celgene Corp. Berkeley Heights NJ, Drug Safety and Surveillance
Safety Records Coordinator (2014-2014)
- Responsibilities Included to Co-ordinate the receipt of AE case reports, specifically:
Retrieve inbound source documents from various databases.
Log the receipt of self-evident follow up as communication in ARISg.
Check initial source doc completeness. Initiate follow-up if needed & log communication in ARISg.
Perform duplicate search. Identify exact duplicate source doc and file.
Perform initial data entry in ARISg. Determine if AE / Non-AE.
Identify Non-AE follow-up needs and generate letters and attachments.
Identify PQ complaint and notify Quality.
- Execute pre-defined follow-up measures and due diligence, specifically:
Pull list of follow-ups to be send by day. Send out follow-up letters, and apply due diligent measures. Print, assemble and send follow-up letters/queries and attachments for all cases.
Generate daily listing of cases that need subsequent follow-up and send subsequent follow-up letters/queries to ensure due diligence is performed.
Review & identify follow-up outside of due diligence measures.
Initiate reminder of further follow-up as needed.
Elevate outstanding follow-up (clinical trial case).
Log all follow-up measures as communication in ARISg.
Otsuka Pharmaceuticals, Inc., Princeton Junction, NJ (2013-2013)
Global Pharmacovigilance (PV) coordinator for all company products.
- Responsibilities included coordinating the global CAPA PV teams for meeting reviews of all product submissions to global authorities, also revisions of SOP’s for the investigator sites, and maintaining the entire global studies list.
EISAI, INC., Woodcliff Lake, NJ (2010-2012)
Coordinator for Medical Review teams of PMRC and MOC across entire Eisai portfolio. (Marketed & pipeline products)
- Responsibilities include coordinating the submission process, meeting agendas, schedule PMRC meetings, and keep records of meeting minutes.
- Proofread the final scientific exchange materials resulting from the PMRC review meetings.
- Maintain the documentation database and library of every version of the materials submitted and the final approved scientific exchange materials.
- Responsible for organizing Medical Oversight Committee (MOC) meetings, and documenting meeting discussion.
- Coordination with other business units and vendors in preparing for conventions / congresses that includes approximately 70+ members and assuring that members will be present in meetings to keep reviews at a minimum length of time.
FOREST LABORATORIES, INC., Jersey City, NJ
Drug Safety Surveillance (DSS) / Compliance & Quality Management Specialist (CQM)
§ Responsible for maintaining the departmental performance and safety case data, as well as, the procedural compliance documents, which served as the basis for most analyses and actions.
§ Managed and tracked the flow of documents and formatted information for root cause and trend analysis.
§ Performed data entry into the quality management system and followed document management procedures to insure the integrity of all records and files.
§ Maintained the compliance electronic mailbox to screen for expedited ICSR’s.
§ Handled the departmental monthly metrics report to monitor safety information with business partners and reports to the FDA. Also, initiated and/or conducted Root Cause Analyses as necessary.
§ Managed the receiving, storing and maintaining of the clinical trial randomization codes for all Forest studies.
§ Subject matter expert and trainer for some company’s new working documents and Job aids.
DSS / Senior Records Specialist (2004-2008)
§ Managed the Master Periodic and Case Report File setup, retrieval, maintenance and tracking from creation to final disposition. This included data entry of drug safety and surveillance documents, scanning all paper adverse drug event reports, periodic safety update reports and aggregate reports to be submit to the FDA.
§ Assisted the DSS staff with future records management implementations and special projects related to FDA submissions. (e.g., managed and supervised six temporary employees for the scanning of all our legacy case reports submitted to the FDA).
SAM ASH MUSIC CORPORATION, New York, NY
Shipping and Export/Customer Service Manager
§ Oversaw the shipping and exportation of professional musical equipment worldwide for over 100 employees.
§ Responsible for preparation of airway bills, commercial invoices, letter of credit and export declaration forms with all the required Schedule-B numbers.
§ Entered data for all the required shipping and export documents.
§ Negotiated rates and opened all accounts with airlines, airfreight and shipping-packing supply companies.
UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO
B.A. Liberal Arts
Knowledge of Microsoft Office, Windows XP, Photoshop, Adobe Acrobat, Clintrace Safety Database, File Maker Pro, Smead Color Bar Gold, TrackWise, ARISg, Lotus Notes, Bilingual in English and Spanish. Understanding of Italian and Portuguese.