Working as clinical pharmacist at national cancer institute for 7 years
Working as ward pharmacist at International Medical Center for 3 years
Working as Pharmacovigilance specialist for a year at insight cro
Overview
17
17
years of professional experience
Work History
Pharmacovigilance Specialist
Insight CRO
01.2024 - 02.2025
Responded to requests from regulatory agencies and notified to share information.
Contributed to the development of risk management plans for new pharmaceutical products.
Collaborated with cross-functional teams to develop comprehensive safety surveillance strategies for clinical trials.
Supported signal detection activities by conducting ongoing monitoring and analysis of safety data from various sources.
Evaluated incoming case reports for completeness, accuracy, and consistency before entering them into the global safety database.
Initiated process improvement initiatives that resulted in reduced case processing times without compromising data quality or integrity.
Read scientific literature and bibliographic sources.
Supported inspections, visits and audits as well as CAPAs management.
Conducted comprehensive literature reviews to stay current on emerging trends in pharmacovigilance practices.
Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
Maintained strong relationships with external partners such as contract research organizations, fostering effective collaboration on pharmacovigilance projects.
Authored and managed regular safety update reports.
Developed innovative solutions for complex case processing challenges, enhancing overall efficiency within the department.
Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
Enhanced drug safety by analyzing adverse event reports and identifying potential risks.
Coordinated closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing studies and spontaneous reports.
Participated in internal audits as well as external inspections conducted by regulatory authorities, demonstrating a solid understanding of applicable regulations and guidelines.
Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
Assessed and distributed pharmaceutical product adverse event documents.
Improved regulatory compliance with thorough documentation of adverse events and follow-up actions.
Developed new or improved pharmacovigilance procedures.
Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
Oversaw adverse events case reporting and conducted follow-up.
Promoted a culture of safety within the organization by championing pharmacovigilance best practices and fostering an environment of open communication and collaboration.
Reviewed, compiled and analyzed data for safety database management.
Exceeded inspection readiness targets through meticulous record-keeping and adherence to standard operating procedures.
Provided subject matter expertise to support the development of training materials, standard operating procedures, and work instructions within the department.
Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
Streamlined pharmacovigilance processes by implementing new software and data analysis tools.
Monitored deliverables for quality and adherence to regulatory reporting timelines.
Expanded knowledge base by attending industry conferences, workshops, and seminars related to pharmacovigilance best practices.
Trained staff and updated training documents to meet regulations and standards.
Assisted in the preparation of periodic safety update reports, ensuring timely submission to regulatory authorities.
Reported problems and concerns to management.
Ward Pharmacist
International Medical Center
11.2015 - 11.2018
Educated patients about possible drug interactions and gave special administration instructions.
Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
Conducted regular audits of the pharmacy''s controlled substances inventory, ensuring accurate record-keeping and preventing diversion or theft.
Developed strong relationships with healthcare providers to optimize patient care and medication adherence.
Reduced medication errors within the pharmacy by developing and implementing a continuous quality improvement program.
Served as liaison between the pharmacy department and other healthcare professionals, facilitating communication regarding patient care plans.
Implemented medication therapy management programs, resulting in improved patient adherence to prescribed medications.
Streamlined prescription refill process to enhance patient convenience and adherence to medication regimens.
Mentored pharmacy students and interns, contributing to development of future healthcare professionals.
Clinical Oncologist
National Cancer Institute, NCI
01.2008 - 04.2015
Served as a key resource for colleagues seeking guidance on challenging cases or specific oncology-related issues.
Developed strong relationships with referring physicians, enhancing communication and continuity of care for patients.
Achieved a high rate of clinical trial enrollment, giving patients access to novel therapies and advancing the field of cancer research.
Educated patients about their diagnosis, empowering them to make informed decisions regarding their treatment plan.
Assessed patients'' needs accurately, employing an empathetic approach when discussing treatment options and prognosis.
Participated in ongoing professional development opportunities to stay informed on emerging trends in cancer therapy and research.
Managed complex cases effectively, utilizing evidence-based practices to guide decision-making and optimize patient outcomes.
Educated patients and families on health conditions to raise awareness.
Administered specialized treatment for multiple patients daily.
Conducted research and stayed current with medical advancements, contributing to growth of medical knowledge.