Safety Coordinator

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DANA R A W S O N E NG E L

EXECUTIVE SUMMARY

Organized self-starter with hands-on appreciation of management of a small business; Broad knowledge of planning, marketing, scheduling, training and management.

Special experience/ability in Excel, accounting/bookkeeping systems and reporting

Pharmacovigilance experience triage, processing cases, sending queries, reconciliations.

PROFESSIONAL EXPERIENCE

CLINIGEN

Medical Information Specialist – June 01, 2023 - December 11, 2023 As the Medical Information Specialist: responsible for answering calls on the MI phone line. Answering questions the caller has about a specific medication. Escalating the call using a warm transfer if the information is not readily available by the Specialist. The data from each call is entered into a database. At the end of the month, reconciliation reports are run and sent to the customer. These reports are also used for invoicing purposes.

Safety Coordinator - February 16, 2017 - December 11, 2023 As the Safety Coordinator: responsible for triaging and assisting with managing serious adverse events

(SAEs) or adverse events (AEs) case management, focusing on the receipt, tracking, and coordination of incoming AE case flow, initial case generation, maintenance of AE case files, extraction of source data, in addition to assistance with. regulatory reporting, queries, data listings and reconciliation, in accordance with Standard Operating Procedures and applicable International Conference on Harmonization (ICH) I Good Clinical Practice (GCP) guidelines. Daily interaction Safety Managers and personnel, third-party vendors, and as indicated with Sponsors or Sponsor safety databases, site personnel, and overall assisting with coordinating the workflow AE case processing and reporting. Assist in maintaining accurate and audit- ready files and assist with various other department administrative needs. From June 2020-December 2023, also completed data entry of the cases including entering demographics, labs, suspect and concomitant medications, medical history, writing narratives, and running reports.

• Monitor and maintain "Triage" inbox each day.

• Immediately assess all SAE/AE reports for minimum case criteria and reportability, escalating as indicated.

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• Track all incoming SAE/AEs including duplicate checks and redaction as indicated.

• Coordinate case workflow daily for assigned projects.

• Generate case file and case file forms and extract clinical source information as indicated.

• Distribute cases to Safety Managers and assist as needed with data entry and action item entry into ARGUS safety database.

• Assist with scheduling, form generation, and tracking all expedited safety reports to appropriate regulatory authority(s), sites, and ethical committees with little to no supervision.

• Assist with correspondence to site personnel and Clinical Research Associate (CRA) staff to gain full documentation for safety events and reconcile any inconsistencies.

• Assist with generating and reviewing various listings for internal or external requirements.

• Assist with safety reporting activities to outsourced CRO or partners to ensure safety and pharmacovigilance needs are met and in compliance with all global regulations.

• Ensure safety issues are promptly communicated to appropriate team members and sponsors.

• Demonstrate initiative to identify and communicate errors, process improvements, or efficiencies.

• Strong attention to detail and performing quality control (QC) with only occasional errors.

• The ability to prioritize multiple projects, involving potentially high volume of time sensitive reports daily.

• Ability to organize and track assignments, deliverables, and job-related activities with moderate oversight.

• Assist with preparing for periodic internal reviews of safety systems, files, and study related documentation of all safety related projects in preparation for agency or sponsor audits.

• Assist with project archival activities, including inventory USB creation, and shipping as required.

• Assist with SOP management, training record filing and tracking, office expenses and reports as applicable.

• Within the past three years, process cases in ARGUS including data entry, creating queries, running monthly line listing reports and reconciliation reports. HR Coordinator - May 2018 - June 2023

Handled a wide range of administrative and executive support related tasks and able to work independently with little or no supervision. Exceedingly well organized, flexible and enjoying the administrative challenges of supporting an office of diverse people. Assist in the full hiring process of employees.

• Help with new-hire procedures: including organizing employee orientation, creating new employee files, administering employee handbooks, and ensuring all necessary paperwork is properly filled out and submitted to appropriate persons.

• Organize, maintain, and update employee HR information as needed.

• Track benefit plans including health care, retirement, Workers Comp etc.

• Make sure all health and safety regulations are followed.

• Execute all employee termination procedures including advising employees on their rights and any benefits they are entitled to.

• Help ensure payroll processes are correct.

• Foster positive employee relations and work to solve any employee issues that surface or are brought to my attention.

• Make sure all employee records are filed correctly and kept confidential.

• Abide by company enforced HR processes and current employment laws and regulations.

• Under the lead of the Senior Director of Global Operations, be a vital source of human pg. 3 ***********@*****.***

resources information answering any questions employees may have. Finance Assistant - Feb 16, 2017 - November 30, 2023 As the financial assistant, duties included:

• Daily monitoring of AP and AR

• Keep the executive team apprised of any danger days in the bank account.

• Monthly involvement in invoicing and creation and emailing of client invoices.

• Follow-up communication to late payment clients.

• Create reports in Quick Books

• Monthly communication with the CPA to assist in creating other reports. WMRA- A PLASTICS RECYCLING FACILITY - RALEIGH, NC

Laboratory Manager/Office Manager/Shipping-Receiving Manager – June 2003 - June 2009

• Oversaw QC department and responsible for increasing the visibility of this department. Implemented higher standard of testing plastics. Communicated with marketing department daily to keep them apprised of any QC issues and vice versa. Analyzed QC data with production data to be proactive in preventing problems. Communicated with customers as well on QC and shipping issues. As Office Manager, made sure A/P and end of month reconciliation is properly completed as well as responsibilities below. In Shipping same responsibilities as Shipping Manager below. Responsible for shipping 9-13 million pounds of material per month with the quality going to the correct customer. Responsible for receiving 12-17 million pounds of good quality material per month. Keep suppliers updated to the quality of their material. Analyze the profit margin and make necessary adjustments to ensure a profit every month.

Office Manager - June 2001 - June 2009

• Create production reports for all Managers, handle paperwork for finished goods production, QC reports, BOL and manifests, and support any other needs the office, shipping & receiving, and maintenance department have such as computer help and Spanish translations. Work on analytical reports and give alternate solutions to problem solving. Also responsible for all invoices being paid by using two different accounting programs (SAI & People Soft). Assist controller in month-end reports and analysis.

Human Resources Director - October 2000 - June 2001

• Handled the signing up of new employees (mostly in Spanish), kept track of safety issues and meetings. Spanish was key in this position as lots of translations were needed in day-to-day activities as well as the translation of documents. Responsible for all respects of OSHA log compliance.

Shipping-Receiving Manager - April 1999 - August 1999

• Handled all aspects of shipping finished goods, tracking inventory and production, keeping track of in- spec material, and troubleshooting problems in these areas. Also, managed six employees and coordinated shipping and receiving activities for three production facilities as well as two storage warehouses. Also, dealt with customers who buy the finished goods, so they receive them in a timely manner and in good pg. 4 ***********@*****.***

shape at a low trucking cost.

Shipping Coordinator - August 1998 - April 1999

• Was responsible for scheduling of trucks and many of the same duties as above. Also, spent much of the time in Excel, revising spreadsheets and/or making new ones, usually to help analyze data for the lab and for production to help run this recycling plant efficiently. BRIDGEVIEW STABLES- HENDERSON, NC

Owner/Operator - May 1992 - Present

Self-employed venture that offers boarding and hay sales. Retired from teaching, training, and summer camps.

EDUCATION

North Carolina State University - Raleigh, North Carolina B.A., 12/1990

• Major and degree in Economics with master’s level work in Econometrics.

• Second Major in Management with concentration in Marketing.

• Minors in Spanish and Animal Science

COMPUTER SKILLS

• Familiar with most software with little difficulty learning new programs.

• Extensive experience and creativity with spreadsheets, especially advanced Microsoft Excel (having taken all course levels)

• Word Processing, especially in Microsoft Word

• A/P Programs- MAS, MAS90, SAI, People Soft, Quick Books

• Time keeping – Kronos, WeWorked

• ArisG

• ARGUS

DANA RAWSON ENGEL

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DANA RAWSON ENGEL 252-***-**** ***********@*****.*** 3

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