Magdalena Wolanin

224-***-**** ad4k6g@r.postjobfree.com Chicago, IL

Safety Pharmacovigilance Clinical Research

Summary:

Medical professional experienced in adverse events, safety surveillance, and regulatory reporting in clinical trial and post market products.

Acquired expertise in pharmaceutical industry setting. Full understanding and application of knowledge for adverse safety reporting in compliance with ICH and GVP and global regulatory bodies including FDA and EMA.

Qualifications:

Accountable for medical assessment and review of medical reporting procedures in compliance with adverse reporting guidelines.

Applied knowledge in case flow process including E2B transmission, data integrity and validation.

Managed timelines for case processing (ICSR) allowing for due process and adherence to regulatory timelines.

Utilized clinical experience and safety guidelines to impact patient safety while adhering to regulations, and standard operating procedures (SOPs).

Collaborative approach with international teams to improve efficiency, clear understanding, and accurate documentation.

Executing with a sense of urgency and due diligence as needed.

Work Experience:

Quality Assurance Compliance Specialist, Contract Sep 2021- Mar 2022

AbbVie, Lake County, IL

Analyzed and reviewed medical complaint files for adverse events and reported to regulatory authorities.

Documented findings in compliance with Good Documentation Practices as well as GMP and GCP.

Identified potentially reportable and non-reportable events and notification to appropriate functional groups and management.

Utilized medical knowledge and medical terminology for medical record review and quality check.

Knowledgeable in FDA and EMA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations.

●Oriented in CAPA implementation as part of process improvement.

Pharmacovigilance Physician Trainee Oct 2020 - Apr 2021

MediPharm Solutions Inc, Somerset, NJ, Remote

●Developed a competent understanding of ICH/FDA and EMA regulations and guidelines affecting safety issues.

●Gained strong knowledge of international drug regulations.

●Firsthand experience in detailed narrative writing for serious adverse events (SAE) reporting.

●Oriented in drug dictionaries coding adverse events using MedDRA.

●Formed a good understanding of drug development and clinical trial phases.

●Identified cases that meet Suspected Unexpected Serious Adverse Reaction (SUSAR) for expedited reporting.

●Performed initial Individual Case Safety Report (ICSR) processing activities, including triage and analysis content for case validation, seriousness, and causality.

● Formed a solid understanding of lifecycle drug development and phases of clinical research.

Medical Reviewer Oct 2018 – Sep 2021

Community Health, Chicago, IL

●Improved health outcomes for the underserved patient population through medical language translation.

●Collaborated with clinical providers to interpret patients' clinical information.

●Presented and interpret patients' adverse event data, including potential drug-related safety concerns.

●Followed up on patient clinical history, including labs, diagnosis.

Postgraduate Clinical Training and USMLE Medical Board Exams Jan 2012 – Dec 2017

Lublin Hospital Systems, Lublin, PL, Hinsdale Hospital, Hinsdale, IL and Mt. Sinai Hospital Chicago, IL

Gave or received a patient handover to transition care responsibility. Collaborated as a member of an interprofessional team.

●Recognized a patient needing urgent or emergent care and initiate evaluation and management. Found system failures and contribute to a culture of safety and improvement.

Medical Case Manager Oct 2010 - Jan 2012

RSA Medical, Naperville, IL

●Analyzed safety-related data and medical case files for insurance underwriting team and achieved a 100% close rate without case reopening.

●Prioritized and case files for patients requesting health insurance eligibility to perfect client satisfaction.

●Maximized productivity by completing case closure with strict time constraints, leading to cost savings.

●Utilized medical knowledge to interpret and collect critical details on condition and treatment.

●Generated medical narratives from source database and patients’ records.

●Uncovered drug history file to including any indications and adverse events reported.

●Followed standard operating procedures (SOP) and HIPAA guidelines.

●Utilized ICD coding, as necessary.

Education:

●Doctor of Medicine (MD), Medical University of Lublin- Lublin, Poland

●Biology, Loyola University of Chicago - Chicago, Illinois

Technical Skills:

●Trackwise, Veeva Vault, Argus, EPIC Electronic Health Records, Word, Excel, Microsoft Office, EDC Rave, Inform, Bilingual in Polish and English language.

Continuing Pharmaceutical Industry Education and Professional Development:

●Uppsala Monitoring Center- Courses including:

oIntroduction to Pharmacovigilance

oSignal Detection Course

oCausality Assessment of Single-Case Reports

●Drug Information Association (DIA):

oMember & Ongoing Education

●MediPharm Solutions Inc:

oTraining Certification in Advanced Drug Safety and Pharmacovigilance

●Healthcare Businesswomen’s Association (HBA)

oMember, Connector, Volunteer

Contact this candidate