Elisabeta Levcovici

- Managed ICSRs for reported SAEs, including triage, seriousness, expectedness, and relatedness.

- Verified and reviewed AEs and SAEs from clinical database to confirm completeness of patient data and accurate data reporting in accordance with the protocol and guidelines. Responsible for tracking and triaging site‑reported AEs, and reviewed summary safety data at regular intervals.

• Continuously updated knowledge base by attending conferences, workshops, and training sessions related to medical writing best practices.

- Authoring, QC, and medical review of subject’s clinical safety narratives and clinical data.

• Ensured compliance with industry guidelines and regulations by closely adhering to established writing standards and processes.

- Recognized missing/incorrect data and initiated missing data queries/data clarification queries to clinical sites regarding AEs/SAEs.

• Created medical education materials tailored to specific audiences, improving overall knowledge retention among healthcare professionals.

- Participated in safety surveillance activities for assigned products.

- Coding safety data (medical procedures/adverse events/medical history, etc) using MedDRA dictionary; coding medications using WHO drug dictionary for multiple global clinical projects.

- Participated in reconciliation of safety databases and clinical study databases for AE reporting and tally.

- Applied ICH guidelines as applicable to medical writing for clinical data.

- Reviewed deliverables, addressed client comments, and performed clean reads.

- Ensured safety processes are maintained and delivered in accordance with corporate, industry, regulatory and trial conduct requirements, and patient safety standards.

- Supported the development of and provided medical and safety advice to project-related documents (Safety Management Plans, Protocols, ICFs, Risk-Benefit Assessments, and IBs).

- Safety database proficiency (ARISg, ARGUS), review and reporting of aggregate reports and other safety data (DSUR, PSUR/PBRER).

- Contributed to the development of internal SOPs, work practices, and process improvement guidelines.

• Combined thorough understanding of therapeutic area with product strategy to meet communication objectives on assigned projects.
• Successfully managed multiple projects simultaneously while maintaining strict deadlines and high-quality output.
• Streamlined the review process for regulatory submissions, reducing overall time spent on document revisions.
• Enhanced readability of medical documents by applying clear and concise language techniques.
• Edited and proofread technical documents for accuracy and consistency.

• Actively sought opportunities for professional development, attending industry conferences and webinars to expand expertise in relevant fields.
• Ensured consistency across multiple review projects by maintaining strict adherence to established protocols and procedures.
• Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
• Increased efficiency, automated routine tasks using specialized software.
• Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary within the stipulated time to comply with service level agreements and regulatory timelines.
• Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
• Deep understanding of the scientific basis for therapies and drug-induced diseases. Knowledge of medical device, vaccines and drug development process;
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide timely feedback to case processors on the errors/discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.
• Maintain awareness of medical-safety-regulatory industry developments

• Enhanced research project outcomes by implementing effective management strategies and ensuring timely completion of milestones.
• Coordinated with external partners to ensure seamless collaboration on joint research initiatives.
• Managed cross-functional teams, fostering a collaborative environment and promoting individual contributions toward project success.
• Evaluated project progress regularly, identifying potential risks and initiating corrective actions to mitigate any negative impact on results.
• Planed, coordinated, and executed assigned research projects.
• Led research team to complete projects within allotted timelines and budgets.
• Developed and enforce research policies and procedures
• Performed daily management of project team and addressed any team issues promptly.
• Acted as primary contact for sponsor communications.
• Reported project progress, status, and issues if any to the sponsor on regular basis.
• Prepared project documentations and research reports for management review.
• Conducted team meetings to discuss about project status and issues.

- Conducted study visits, ensure study protocols are adhered to and serve as the main contact person for all study participants.

- Recruited potential study participants in various clinics

- Completed all regulatory documentation to the Human Investigations Committee for all studies including protocol submissions, continuations and amendments.

- Assisted PIs and grant administrators with grant preparation.

- Assisted other study coordinators with their duties.

- Processed and prepared blood and urine specimens according to study protocol.

- Completed all data entry for assigned studies.

- Mentored and led clinical research interns and volunteers.

- Implemented quality control measures for all components of research coordination.

- Participated in symposiums, lectures and ground rounds.

• Improved data quality by implementing rigorous data management procedures and conducting regular audits.
• Mentored junior clinical research coordinators in best practices for trial management, fostering professional development and growth within the team.
• Reduced study deviations through meticulous documentation of informed consent processes, eligibility assessments, and visit details.
• Accelerated study completion by effectively managing clinical trial schedules and coordinating site visits.

• Explained study procedures, findings and diagnoses to patients to promote understanding of disorders and recommended treatments.
• Mentored junior technologists as they entered the profession, sharing valuable insights gleaned from years spent working in the field.
• Educated patients on the importance of proper sleep hygiene, leading to improved overall health.
• Collaborated with interdisciplinary teams to optimize patient care outcomes related to sleep disorders.
• Applied electrodes and sensors to patients for sleep studies.
• Contributed to the success of a high-functioning sleep center through effective communication and teamwork.

Developed and implemented community-based health and awareness programs designed to promote healthy eating and physical activity behaviors in children.

- Assisted in coordination and implementation of youth-based fitness and nutrition parent programs and research opportunities.

- Directly engaged with children and taught courses on exercise and healthy habits

Directly implemented components of patient’s treatment plan safely and effectively as directed by the chiropractor/physiotherapist.

- Monitored patient progress and provided hands-on assistance with clinic equipment and various therapy procedures.

- Utilized physiotherapy related devices such as tens unit, short-wave, IFC traction (lumbar, cervical) and apply massage ultrasound, ice and heat packs to patients.

- Assisted in developing plans for patients with complex therapy needs.

- Functional knowledge of both the clinical and administrative operations of a physical therapy facility.

- Created an effective filing system for patient medical documentation.

- Clinical rotations in Internal Medicine Emergencies, Surgery Emergencies and Family Medicine (including Pediatry, Ob-Gyn, and Geriatrics).

- Created SOAP notes and performed follow-up exams.

- Obtained patients’ medical histories, performed general/focused physical exams, interpreted lab results, monitored and recorded patients’ daily status.

- Performed injections and various diagnostic procedures.

- Advised patients about medications and special diets.

- Advised patients and their families on health care including health promotion, disease, illness and accident prevention.

- Prepared case presentations for rounds and seminars and participated in discussions on patient’s management and follow-up.Implemented preventive health strategies for at-risk populations, reducing incidence of chronic diseases in the community.

• Educated patients and families on benefits of healthy diet and adequate exercise.
• Reviewed patient allergies, problems, medications, and immunization statuses.