SUMMARY:

• 13+ years of pharmaceutical industry experience supporting Pharmacovigilance and Regulatory Information Management data teams.
• Well versed in implementing User Acceptance Testing (UAT) and creating test scripts.
• Assisted in the Project Management for developing database enhancements while at Confidential .
• Excellent communicator with the ability to contact with functional heads and vendors to identify database enhancement needs.
• Maintains and tracks deliverable timelines and Request for Proposals.
• Extensive MS Excel experience including: report generation for stakeholders and Leadership Teams
• Able to interview upon request.

TECHNICAL SKILLS:

Microsoft Office Suite, including Word, Excel, Access, Outlook and Power Point.

AgilePV, SAP, SAP DMS, TrackWise, Business Objects, eDocs, Liquent Insight (TRACTS and PRISM).

SharePoint, Acorde, Aegis (ARISg), ARGUS, Documentum, WebCat, Smeadlink, RMS and XMS.

PROFESSIONAL EXPERIENCE:

Confidential, Deerfield, IL

Information Analyst

• Proactively worked with the GRA business to maintain and align system dictionaries/code lists to the appropriate company/industry/agency standard(s).
• Collaborated with data owners to ensure that data is entered into the company’s RIM system(s) in compliance with company/industry/agency standard(s).
• Acted as a quality gatekeeper to ensure compliance with the company’s Regulatory Information data standard is maintained at all times.
• Managed resolution of any resulting Quality Investigations or CAPAs with internal stakeholders/ QA.
• Prepared and ensured the submission of data and supporting documentation to external agency databases (i.e. XEVMPD, ISO IDMP) follows agency requirements and standards. Actively contributed to responses to agency queries raised because of making these submissions.
• Built strong working relationships with information providers/verifiers (primarily) within GRA to encourage and support accurate, timely and reliable entry of Regulatory information into the company’ s RIM system(s).
• Supported the RIM team in the interrogation of Regulatory Information to identify trends that can be presented in business intelligence reports to management.
• Proactively monitored relevant agency guidelines/regulations that are noticed during everyday business to ensure that potential impacts/new requirements are identified and managed at the optimum time.

Confidential, Bannockburn, IL

Sr. Clinical Data Specialist

• Served as a data integrity escalation point to the downstream Pharmacovigilance data team.
• Ensured consistent interpretation of system related conventions, specifications, definitions between GIT and GDS functional areas.
• Collaborated with report requestor to ensure accurate interpretation of the data request.
• Generated accurate ad - hoc reports and scheduled submission compliance reports.
• Prepared E2B for submission.
• Standardized queries to ensure consistency of reports generated.
• Provided system support to global database users.
• Collaborated with project teams in the development and enhancement of system performance.
• Developed and participated in user acceptance testing of system changes in relation to data queries and report generation.
• Coordinated, participated, and led Information Management tasks/projects requiring technical expertise with respect to the Pharmacovigilance Database.
• Trained GDS team members on database queries and other database related tasks in close collaboration with GDS Systems and IT.
• Assisted in development of Information Management-related SOPs.
• Collaborated with cross-functional areas and served as liaison to vendors in strategy development.
• Acted as Database Administrator.
• Performed Project Management in developing database enhancements.

Confidential, ILake Forest, IL

Regulatory Specialist (Contractor)

• Participated in Register Remediation Project.
• Generated reports outside of TrackWise database through Business Objects.
• Generated SAP reports for drug products.
• Identified all source documents required for drug products.
• Formulated reconciliation of data.
• Generated Open Report and Withdrawn Registration metrics.
• Provided training for new and current associates.

Confidential, Abbott Park, IL

Registration Compliance Analyst (Contractor)

• Reviewed updated data/information for Abbott products, for submission to the FDA and foreign regulatory agencies.
• Communicated with foreign affiliates and monitored data clarification.
• Collected data and created metrics for global submissions and the subsequent approvals.
• Tracked registration information through the TRACTS database.
• Executed the eCTD migration project for the CCT group.
• Ensured that Global Labeling CCDS updates are maintained.
• Created and executed queries for global customers.
• Generated reports with TRACTS and COGNOS.
• Made updates within SharePoint.
• Created affiliate Correspondence links between TRACTS and eDocs databases.
• Ensured that communications and commitments are maintained with the system.
• Remediate TRACTS data.
• Participated in the training of new associates.

Confidential, Melrose Park, IL

QA Documentation Clerk/Document Coordinator (Contractor)

• Formulated and edited New Product Templates for the Master Batch Records.
• Tracked and audited controlled documents and change notice requests in Documentum and circulated through the review and approval process.
• Prepared archived materials for off-site storage.

Confidential, Bannockburn, IL

Sr. Records Technician, Regulatory Affairs (Contractor)

• Worked in a Documentum-based environment.
• Assisted in a Records Migration Project.
• Input and scanned records consisting of Annual Reports, Protocols, IND Reports and Investigator Reports into the RMS database.
• Monitored and input Validated Systems files.
• Tracked and stored records at the on-site facility.
• Prepared records for permanent off-site storage.

Confidential, Deerfield, IL

Safety Coordinator, Pharmacovigilance and Product Safety (PSP) (Contractor)

• Acted as Project Lead by formulating and implementing the File Management Process.
• Initiated contact with vendors in the development stage of the File Management Process.
• Managed File Room consisting of Adverse Event Records and Annual Reports.
• Formulated Case File Tracking System Project and served as consultant and primary contact for vendor.
• Developed and executed the data migration program to migrate ARGUS Data to Case File Tracking System database.
• Tracked PSP Safety File through lifecycle of reporting process.
• Corrected PSP Safety Files for cataloging and archival.
• Served as Administrator and Manager of Smeadlink database.
• Coordinated project directives in the interest of enhancing the proficiency of PSP.
• Updated and re-organized PSP Safety File Room.
• Developed User Acceptance Testing (UAT) for Smeadlink Database.
• Formulated training materials for PSP staff.
• Trained staff on the use of database.

Confidential, Abbott Park, IL

Document Specialist (Contractor)

• Monitored and updated Drug Master Files and Investigator Reports.
• Served as liaison for Pharmacovigilance Department to the Regulatory and QA departments, as well as to vendors, to refine and update the Document Management Process.
• Prepared Adverse Event Report Case Files for Archival and for physical and electronic transfer to an off-site storage facility.
• Corrected PV Case Files for proper cataloging.
• Refined and implemented the process of management and retrieval of case files from both the on-site and off-site locations for current workflow.
• Re-organized the Central File Room to house Adverse Events Records and Annual Reports.
• Created a format for PV Case File Requests to be utilized throughout the department.
• Provided lead and direction for updating and renovating projects within Global Medical Services.

Confidential, Abbott Park, IL

Operations Support, Corporate Disbursement Operations (Contractor)

• Contacted outside vendors to retrieve lost invoices not in the system.
• Served as liaison for Accounts Payable to more than one thousand vendors, contractors, and physicians.
• Identified and corrected errors in Accounts Payable and Expense Reporting in relation to the Optika imaging system and the Abbott mainframe in preparation for the compliance audit.
• Updated, reconciled, and maintained Optika and CAS databases.
• Monitored scan logs for both Accounts Payable and Expense Reporting.
• Researched and collected data for Security in Expense Reporting.