Pharmacovigilance - Medical Reviewer
Resume:
WALE OGUNDIPE, MD, CPHT, ADSP CERTIFIED
*************@*****.***
SUMMARY OF QUALIFICATIONS
Versatile and driven pharmacovigilance (PV) physician with expertise in the medical review of Individual Case Safety Reports of Clinical Trial and Post-marketing cases. Proficient in performing safety reviews of clinical trial protocols, clinical study reports, and other study-related documents. Demonstrated ability to support implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator's Brochure, and other key safety documents.
3+ years of experience in the pharmaceutical and biotech industry, specializing in PV practices. Possess a robust healthcare background and committed to ensuring patient safety and efficacy of pharmaceutical products through meticulous signal detection, risk management, and regulatory compliance.
PROFESSIONAL EXPERIENCE
ORCIMED LIFE SCIENCES
Boston, Massachusetts
Medical Reviewer, Drug Safety 06/2021 to Current
Monitor the relevant safety data from various sources on an ongoing basis, including the medical review of individual Serious Adverse Events (SAEs)/Adverse Event of Special Interests (AESIs)/Pregnancy cases (review the medical coding, medical query, expectedness assessment, company causality assessment, etc.) from clinical trials.
Contribute to the authoring/review of safety sections of the clinical study protocols, Investigator Brochures, Informed Consent Forms, and safety assessment reports.
Support routine signal detection activities through evaluation of signals from Individual Case Safety Reports (ICSRs) and other sources. Participate in signal review meetings.
Ensure safety data quality and data integrity is maintained.
Perform monthly review of line listing of cases to evaluate coding and labelling, for all ongoing studies.
Contribute to solving reconciliation medical coding issues or discrepancies.
ONCOLOGIE
Waltham, Massachusetts
Drug Safety Associate 02/2021 to 06/2021
Managed adverse event and device reports in accordance with local and global standard operating procedures (SOPs) and regulations: case processing- responsible for initial review, triage, entry, assessment, and acknowledgement of adverse event reports (clinical trial, post marketing study, spontaneous, literature, pregnancy, and regulatory cases) into the PV database.
Performed post-data entry quality check of safety data for medical accuracy, completeness, consistency, and adherence to company SOPs- case processing.
Developed, implemented, and maintained resource tools for collecting complete and quality data through appropriate case follow-up with affiliates, sales reps, healthcare professionals and patient support programs.
Ensured regulatory compliance for expedited submissions of case reports- verified that qualifying case reports are identified for expedited reporting for submission to regulatory authorities within the defined timelines.
Collaborated with internal and external customers- ensured compliance with business alliance agreements.
Provided appropriate training to all customers relating to PV and company SOPs- trained nurses, pharmacists, and sales representatives on what constitutes an adverse event and the reporting procedures.
FEDERAL MEDICAL CENTER
Abeokuta
Senior Medical Officer 10/2016 to 02/2021
Coordinated outpatient clinics and collaborated with attending physicians to review inpatient cases, optimizing the continuum of patient care. Improved clinic efficiency through streamlined coordination and initiative-taking case reviews, ensuring timely and effective healthcare services.
Organized health talks for the community, promoting preventive healthcare measures and raising awareness on relevant health issues. Engaged with diverse audiences, resulting in an increase in community participation and initiative-taking health-seeking behaviors.
Effectively communicated on reportable diseases to local government authorities, ensuring timely and accurate reporting. Played a key role in early detection and containment efforts, contributing to a reduction in the spread of communicable diseases in the community.
Developed comprehensive data management plans and reports, along with validation procedures and data entry processes. Enhanced data quality and integrity, leading to a reduction in data-related errors and improved overall reliability of clinical information.
FEDERAL MEDICAL CENTER
Abeokuta
Intern Physician/ Medical Officer 09/2012 to 10/2016
Actively engaged in rotations across various medical specialties, gaining valuable experience in different fields of medicine. Developed a comprehensive understanding of medical disciplines, fostering a holistic approach to patient care and strengthening clinical skills.
Collaborated with interdisciplinary teams to optimize patient care plans and enhance treatment outcomes. Demonstrated effective communication skills, resulting in an improvement in team collaboration and coordination.
Effectively managed medical histories, recorded vital signs, and explained treatment procedures to patients. Trained newly hired staff on these processes, ensuring consistent and high-quality healthcare services. Contributed to the smooth onboarding of new team members.
Provided patient education on medications, special diets, hygiene practices, and effective disease prevention methods. Improved patient understanding and adherence to treatment plans, resulting in an increase in patient compliance and overall health outcomes.
EDUCATION AND TRAINING
Medical Degree: Bachelor of Medicine and Surgery - Igbinedion University College of Medicine 2012
OTHER PROFESSIONAL EDUCATION/CERTIFICATIONS
National Institute of Health - Principles of Clinical Pharmacology 2020
National Institute of Health - Principles and Practice of Clinical Research 2020
National Health Care Provider Solution - Bloodborne Pathogens Completion Certificate 2020
National Healthcare Workers Association - Certified Pharmacy Technician (CPhT) 2019
MEMBERSHIP IN PROFESSIONAL ORGANIZATIONS
Member Medical and Dental Council
Member Phi Theta Kappa Honor Society
SKILLS
Expertise in Good PV Practices and Good Clinical Practices
Proficient in Argus and ArisG database management and MedDRA coding
Proven ability to manage and prioritize tasks in a demanding environment
Strong analytical skills for signal detection and risk assessment
Experienced in post-marketing and clinical trials
Excellent communication and documentation skills for internal and external stakeholder engagement
In-depth knowledge of FDA, EMA, MHRA and ICH regulations
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