Mya Lorenz
Vernon Hills
Summary
Accomplished professional with strong analytical abilities, communication skills, and a collaborative mindset. Demonstrates a proven talent for adapting swiftly to new environments. Proven ability to handle multiple tasks effectively. Committed to contributing to team success while embracing opportunities for professional development. Recognized for taking a proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.
Overview
29
29
years of professional experience
Work History
Sr. Drug Safety Scientist
Fresenius Kabi USA, LLC
09.2020 - Current
- Review the safety database to identify cases reportable to the FDA and delegate these cases to QC for verification prior to submission to the FDA.
- Conduct reconciliation of adverse events with contract manufacturers in accordance with the terms outlined in the Safety Data Exchange Agreement.
- Took the initiative to update the evolving verbatim term assessment document.
- Compiled detailed meeting minutes from the KabiSafe Exchange Meeting and the Medical Managers Meeting to share with local colleagues.
- Actively engage in monthly meetings to review case processing observations and work with global colleagues to ensure timely processing of cases while maintaining quality and accuracy in ICSRs.
- Developed a dynamic QC checklist to ensure accurate data entry of cases into the safety database, aligning with SOPs, as well as FDA and EMA guidelines.
- Developed an evolving product reference sheet to determine the appropriate ANDA/NDA for each product and the applicable USPI for labeling purposes.
Drug Safety Scientist
Fresenius Kabi USA, LLC
02.2016 - 09.2020
- Reviewed the safety database to identify cases reportable to the FDA and assigned them to QC for verification before submission to the FDA.
- Provided training to new contractors and employees on case processing procedures as a qualified trainer.
- Conducted reconciliation of adverse drug events with contract manufacturers in accordance with the Safety Data Exchange Agreement (SDEA)
- Executed QC review and data clean-up of Periodic Adverse Drug Experience Reports (PADERS).
- Performed MedDRA and WHO coding for adverse drug events and associated products.
- Managed incoming calls from healthcare professionals and consumers regarding adverse events and made outbound calls to gather additional information.
- Completed E2B submissions of adverse events to the FDA.
Clinical Safety Analyst
AbbVie
02.2014 - 08.2015
- Gathered, analyzed, and prioritized adverse events, including reporting serious adverse events to IND safety and managing follow-up activities.
- Reviewed and assessed safety-related data from oncology clinical trials to ensure content quality and compliance with regulatory guidance and protocols.
- Collaborated with the Study Designated Physician to create a Safety Review Plan for the assigned protocol.
- Verified the accuracy of MedDRA and WHO coding reports.
- Served as study lead for assigned protocols, overseeing study start-up activities through to study closure.
Safety Review Specialist
Baxter Healthcare Corporation
06.2010 - 02.2014
- Acted as the primary point of contact and conducted quality checks on all vendor-processed cases, ensuring timely and accurate submissions.
- Facilitated weekly meetings with the vendor to address case quality and resolve case processing inquiries.
- Executed E2B submissions to ensure compliance with reporting requirements.
- Owned the Corrective Action/Preventative Action (CAPA) process, investigating root causes of non-conformance and collaborating with relevant parties to implement effective action plans.
Clinical Operations Manager
American Imaging Management
05.2001 - 06.2010
- Enhanced clinical operations by collaborating across departments and educating nurses, referral specialists, and physician reviewers on the appeals process and documentation requirements.
- Led the team in securing the Independence Blue Cross (IBC) account.
- Worked with staff to obtain licensure for conducting utilization reviews in the state of Texas.
- Actively participated in client delegation audits to ensure compliance and quality.
- Designed and implemented an appeals process aligned with health plan requirements, NCQA standards, ERISA regulations, and DOL guidelines.
- Collaborated with colleagues to establish a call center in Westchester, IL and Glendale, CA.
Phone Triage Nurse
Northwest Healthcare Associated
01.1999 - 05.2001
- Collected case histories and triage information to identify the most suitable care pathway.
- Provided guidance to family members and caregivers on patient care instructions.
- Scheduled appointments for patients requiring non-emergency examinations, coordinating directly with providers as necessary.
- Delivered patient education and advice, including pre- and post-operative care, medication administration, follow-up appointments, and recognizing symptoms that may require emergency attention.
High Risk Antepartum Staff Nurse
Evanston Hospital
06.1996 - 12.1999
- Provided comprehensive care for expectant mothers throughout their pregnancy, including monitoring lab results, conducting fetal heart monitoring, and educating mothers about upcoming stages of pregnancy.
- Guided new mothers in breastfeeding techniques, postpartum self-care, and infant care to support a smooth transition into motherhood.
- Responded effectively to emergency situations such as pre-eclampsia, early labor, and fetal distress, ensuring patient safety.
- Evaluated infant health immediately after birth, performed vital checks, and administered post-birth vaccinations to newborns.
- Collaborated closely with physicians to assess patients rapidly and implement appropriate treatments in dynamic and urgent conditions.
Education
Bachelor of Science - Nursing
North Park University
05.1996
Skills
- Proficient in software applications
- Team leadership
- Effective communication
- Analytical thinker
- Cross-functional teamwork
- Self-motivated
- Strong interpersonal connections
- Effective change management
- Receptive to diverse perspectives
- Commitment to continuous learning
Credentials
R.N.
Degree
B.S.N.
Timeline
Sr. Drug Safety Scientist
Fresenius Kabi USA, LLC
09.2020 - Current
Drug Safety Scientist
Fresenius Kabi USA, LLC
02.2016 - 09.2020
Clinical Safety Analyst
AbbVie
02.2014 - 08.2015
Safety Review Specialist
Baxter Healthcare Corporation
06.2010 - 02.2014
Clinical Operations Manager
American Imaging Management
05.2001 - 06.2010
Phone Triage Nurse
Northwest Healthcare Associated
01.1999 - 05.2001
High Risk Antepartum Staff Nurse
Evanston Hospital
06.1996 - 12.1999
Bachelor of Science - Nursing
North Park University
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