Hi, I’m
Mubarak Kukoyi MD
South Holland,IL
The way to get started is to quit talking and begin doing.
Walt Disney
Summary
Highly skilled and enthusiastic professional with more than thirteen years of combine experience in pharmaceuticals and clinical practices, managing and educating junior doctors and scientist. Successfully oversee signal detection and aggregate reports. Made patient safety a priority at all time collaborate with cross functional areas for the success of our products.
Highly enthusiastic, and motivated drug safety professional with strong skills, abilities, and passion for medical review of individual case safety reports (ICSR- AE, SAE, AESI, SUSAR) within assigned studies, both clinical trials and post-marketing. Able to review aggregate reports, and collaborate with cross-functional departments, including regulatory affairs, compliance, and clinical development. Excellent skills in providing oversight and key input for the review of new and ongoing safety documents, such as DSUR, PSUR, and PBRER. Adept at offering knowledge to pharmacovigilance plans, and risk minimization actions in the core RMP, and internationally evaluated LRMPs. Significant skills in signal detection, validation, analysis/work-up and final interpretation. Support audits and regulatory filings with FDA and EMA during IND/NDA/BLA submission. Provides causality, listedness, seriousness & reportability assessment of cases.
Overview
12
years of professional experience
Work History
Astellas Pharmaceuticals
Associate Medical Director /Medical Reviewer
03.2022 - Current
Job overview
- Ensure that all pharmacovigilance obligations are fulfilled to support assigned clinical trial program and post-marketed products
- Participate and contribute to key regulatory filings such as IND and BLA filing. Contribute to authoring study protocols and investigators brochure
- Oversee clinical assessment of adverse events, SAEs, SUSARs, and safety signals collected from clinical trials, and post-marketing surveillance in the assigned therapeutic area
- Respond to regulatory inquiries from health agencies and IRBs on safety and scientific questions of assigned products
- Prepare and review Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans
- Author Pharmacovigilance and Safety Data Exchange Agreements with collaborating business partners
- Review and give medical opinions on various reports originating from the literature
- Review literature references for signal detection and aggregate reports
- Identify and implement proactive safety analysis strategies to further define the safety profile
- Propose measures to minimize risks during clinical development, and update development risk management plans (DRMPs)
- Interact with internal and external stakeholders to ensure monitoring of safety profile, signal validation, and signal evaluation
- Review input to aggregate reports (DSUR, PSUR, PBRER) and development risk management plans (RMP)
- Lead ongoing safety data review during clinical trials through Safety Plans and safety review meetings (SRM)
- Ensure effective collaboration with the Strategy & Innovation Group, Clinical Development group, GSO for the surveillance of assigned product to the Global Authorities and the other stakeholders
- Provide guidance and medical support to the safety scientists in charge of case processing, without a direct reporting line
- Manage and Supervise all ongoing safety surveillance of company products both in clinical trials and post marketing, including my assigned products, the implementation and oversight of electronic surveillance of core safety and the training of new or junior physicians and scientists in collecting data.
Glonerg Consulting
Pharmacovigilance Physician / Medical Reviewer
04.2017 - 11.2021
Job overview
- Provided support to product safety lead in activities relating to monitoring and management of Product's emerging safety profile
- Assist the Safety & PV leadership with the SMT/Safety Review Teams for development compounds/ assigned products and is responsible for the management of ongoing and cross-functional assessment of benefit-risk profiles
- Contributed to signal detection activities by supporting monitoring, evaluation, interpretation, management and communication of safety information
- Supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Safety Physician in determining the impact of the safety issue on the product’s benefit/risk profile
- Participated in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature
- Identify additional information required from investigators and collaborate to prepare queries to be requested
- Performed Analysis of Similar Events for events of special interest
- Supports the logistics of Safety Management Team (SMT) / Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and minutes/communication
- Prepared materials (Slides, etc.) in preparation of Company Safety Committee meeting with input support safety publication
- Assist Safety & PV team with the Medical content of Risk Management documents for the assigned products.(RMPs, REMS)
ProPharma Group
Drug Safety Scientis
10.2014 - 02.2017
Job overview
- Performed applicable safety surveillance activities for assigned products; and in planning and completion of Ad-Hoc Safety Reports as needed
- Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians by interfacing with sponsor study managers, Clinical Research Organizations, Clinical Research Associates, Pharmacovigilance and others to assure query resolution
- Supervise tracking of safety -related queries to Investigators and assists in handling safety questions from IRB/IEC
- Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data
- Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency
- Prepared meeting materials and presented to safety department scientists and physicians on ongoing safety issues
Bailey Outpatient Medical Services
Medical Officer
04.2012 - 05.2014
Job overview
- Obtained medical history and made an initial physical examination of patients, documented that on the patient’s file under the supervision of a licensed physician.
- Responded to patients' wellness-related questions, and the physical, emotional, and developmental needs of patients
- Continuously maintained proper safety and took precautionary measures to avoid the spread of disease and infectioN
- Directed and coordinated patient care activities of nursing and support staff.
- Completed patient referrals to other medical specialists.
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Verified complex diagnoses to facilitate treatment plans.
- Reviewed outpatient records and interpreted documentation to identify diagnoses and procedures.
- Reviewed patient charts to better understand health histories, diagnoses, and treatments.
General Hospital Lagos Island
Medical Officer (physician Houseman-ship Job)
01.2011 - 02.2012
Job overview
- Directed and coordinated patient care activities of nursing and support staff.
- Improved patient outcomes and delivery of care through improved clinical quality processes.
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Interpreted diagnostic test results for deviations from normal.
- Confirmed consistent and accurate medical recordkeeping practices.
- Ordered medical and laboratory supplies and equipment.
- Kept informed on advancements in field to contribute to medical research programs.
- Communicated with patients, ensuring that medical information was kept private.
- Defined testing protocols, quality assurance initiatives and clinic policies and procedures.
- Ordered all pharmacy supplies and kept check on inventory levels.
- Designed and introduced leadership development, coaching and team management model, resulting in promotion of employees into increased levels of responsibility.
Education
SPARTAN Health Science University St. Lucia
M.D. from Osteopathic Medicine
08.2010
KENNEDY KING COLLEGEChicago, IL
Associate of Science from SCIENCE
05.2004
Olive -Harvey College Chicago, IL
Associate of Science from Applied Science
12.2002
Skills
CORE QUALIFICATIONS
- Hands-on experience in drug safety research, signal evaluation, tracking and documentation activities in Phases I II, III and IV Clinical trials
- Immense knowledge of clinical trial drug development process, pharmacovigilance, and drug safety principles
- Experience with authoring, contributing, reviewing and analyzing data safety section of aggregate reports ie DSUR, PSUR, / PBRER, PADER, monthly line listing, and clinical study reports CSRs, DSURs, and responsible to ad hoc inquiries from Regulatory Agencies [Eg FDA, EMA, Health Canada, MHRA, PMDA, etc]
- Author, review and analyze data in safety sections of DSUR, PSUR, PADER, 6-month SUSAR Line Listing
- Operational knowledge of using EDC Medidata, Argus safety database, Veeva, Spotfire and Empirical Signal
- Ability to create and implement risk management plans for new investigational products durinG IND/BLA
- Author and review SAE forms, SMP, SAE Reconciliation Plan, safety reports and SOPs
- Argus, Arisg, Veeve safety data base, end of line Case Processing & Medical Review: AE, SAE, AESI, and SUSAR cases within the regulatory timelines
- Reviews, edits and updates documents related to ongoing trials such as monitoring plans, SOPs, ICFs Amendments according to IRB/IEC submissions and regulatory rules
- Ensures that all the activities and clinical programs are in compliance with the ICH-GXP rules and regulatory requirements, both local and institutional regulations
- Highly skilled at interpreting complex clinical trial data while providing explanation to all stakeholders
- Ability to interpret and follow international Drug Safety reporting regulations and guidelines (CIOMS, FDA, EMA)
- Experienced with corporate agreements and oversee the implementation of such agreements
- Authored and timely Revised SDEAs with SME and corporate partners
- Managed and enhanced SDEAs with stakeholders for inspection readiness
- Follow up for the on-time implementation to improve the efficiency and effectiveness on stakeholders agreement
SIGNATURE SKILLS
- Safety Management Plan
- Medical Review, Causality assessment, Listedness assessment
- Signal Detection [ signal assessment, signal prioritization, signal validation, signal management and exchange of information]
- Empirica Signal, Spotfire
- Aggregate reports [DSUR, PBRER & PADER]
- Electronic Data Capture systems [EDC CRF]
- AE/SAE Case Processing
- MedDRA/WHO DD Coding
- Expedited SUSAR Reporting
- Argus/ArisG Safety Database
- Clinical practice experience
- EDC- Oracle Medidata, Inform and express
- ICH/GVP, FDA, and IRB guidelines
- CITI Program (HIPAA)
- Aggregate Report Generation
- Quality & Peer Review
- Protecting research participants
- Literature surveillance (OVID, RIGHT FIND)
THERAPEUTIC AREA EXPERIENCE
- INfectious Desiese: COVID, Tuberculosis, Hepatitis B, Meningococcal infections, Influenza, Ebola, Malarias Phase I and II
- Hematology (sickle cell disease, PNH) and hematological malignancies (ALL, CLL)- phase II and III studies
- Central Nervous System: Parkinson, Alziemers Pain management with monoclonal antibodies of anti-NGF- phase II
- Oncology (immunotherapy/RECIST review, iRECIST): Solid tumors- Urothelial, breast and colon cancer
- Vaccine: live- attenuated vaccine, Messenger RNA (mRNA) Toxoid Vaccine Phase II and III
- Gastro-Intestinal: autoimmune (Crohn's Disease) Hemochromatosis and other GI Pathologies phase II and II
- Ophthalmology / Endocrinopathy: Thyroid Cancer & Graves’ disease, Ophthalmopathy- phase 1 and II
- Cardiovascular: Hypertension, cardiac failure- phase II and III
- Rheumatology: Osteoarthritis, Gouts, Fibromyalgia- phase I to II
- Rehab and Pain Management- phase II and III studies
Languages
English
Native or Bilingual
Yoruba
Native or Bilingual
Additional Information
CLINICAL TRAINING (STUDENT INTERN) JAN 2008 - JULLY 2010
SPARTAN HEALTH SCIENCE CHICAGO ILL.
Medical Clinical Clerkship / Doctor of Medicine student
Rosemont Medical center ( Internal Medicine)
Loretto Hospital ( Geriatrics)
Jackson Park Hospital.
- Performed patient examinations, diagnosis, and treatments under supervision of resident physicians
during clinical rotations. - Collaborated with multi-disciplinary healthcare teams to ensure delivery of optimal patient care
Rotations included:
Family Medicine, Internal Medicine, and Psychiatry at Norwegian American Hospital
Surgery, Pediatrics, Radiology, and Pathology at Saint Bernard Hospital
Emergency Medicine, Gastroenterology, and Vascular Surgery at Loretto Hospital - Reviewed new and existing patient’s information on a daily basis.
- Assisted Attendings with patients’ physical examination, check-up, diagnosis, treatment, assessments and plan.
- Worked in collaboration with doctors, nurses and other healthcare administrators.
- Consulted and screened diabetic, hypertensive patients and monitored treatments.
- Consulted and performed physical assessments on patients in nursing homes.
- Participated in community prevention and health promotion programs, and provided presentation on “preventing
- diabetes.”
- Assisted in evaluation of laboratories: CMP, CBC, Lipid panel etc.
TRAINING AND CERTIFICATIONS
- Clinical Research Training and Certification NIH Bethesda MD
- Education Commission for foreign Medical Graduate ( ECFMG)
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Associate Medical Director /Medical Reviewer
Astellas Pharmaceuticals
03.2022 - Current
Pharmacovigilance Physician / Medical Reviewer
Glonerg Consulting
04.2017 - 11.2021
Drug Safety Scientis
ProPharma Group
10.2014 - 02.2017
Medical Officer
Bailey Outpatient Medical Services
04.2012 - 05.2014
Medical Officer (physician Houseman-ship Job)
General Hospital Lagos Island
01.2011 - 02.2012
SPARTAN Health Science University
M.D. from Osteopathic Medicine
KENNEDY KING COLLEGE
Associate of Science from SCIENCE
Olive -Harvey College
Associate of Science from Applied Science