Bola Kukoyi. MD

Chicago, IL *****

312-***-****,

adt77b@r.postjobfree.com

PROFILE

Highly enthusiastic, and motivated drug safety professional with strong skills, abilities, and passion for medical review of individual case safety reports (ICSR- AR, 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.

CORE QUALIFICATION

●Hands-on experience in drug safety research, signal evaluation, tracking and documentation activities

●Immense knowledge of clinical trial drug development process, pharmacovigilance, and drug safety principles

●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 Empirica Safety

●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 Case Processing & Medical Review: AE, SAE, AESI, and SUSAR cases within the regulatory timelines

●Ability to interpret and follow international Drug Safety reporting regulations and guidelines (CIOMS, FDA, EMA)

SIGNATURE SKILLS

●Safety Management Plan

●Medical Review, Causality.

Signal Detection & Listedness

●Empirica Signal, Spotfire

●DSUR, PBRER & PADER

●Electronic Data Capture systems

●AE/SAE Case Processing

●MedDRA/WHODD Coding

●Expedited SUSAR Reporting

●Argus/ArisG Safety Database

●Clinical practice experience

●Expedited SUSAR Reporting

●EDC- Oracle Inform & Medidata

●In Outpatient Care

●GCP, FDA, and IRB guidelines

●CITI Program (HIPAA)

●Aggregate Report Generation

●Quality & Peer Review

●Protecting research participants

CAREER OVERVIEW

CHARIS ASSOCIATES - SHERIDAN. WY Sep 2019 – Present

Pharmacovigilance Physician/Medical Reviewer

Key Contribution:

●Ensured that all pharmacovigilance obligations were fulfilled to support an assigned clinical trial and to ensure subject safety

●Participate in key regulatory filings such as IND and BLA. Contribute to authoring study protocols and investigators brochure

●Oversaw 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

●Prepared and reviewed Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans

●Author Pharmacovigilance and Safety Data Exchange Agreements with collaborating business partners

●Reviewed and gave medical opinions on various reports originating from the literature

●Reviewed literature references for signal detection and aggregate reports

●Identified and implemented proactive safety analysis strategies to further define the safety profile

●Proposed measures to minimize risks during clinical development, and updated development risk management plans (DRMPs)

●Interacted with internal and external stakeholders to ensure monitoring of safety profile, signal validation, and signal evaluation

●Reviewed input to aggregate reports (DSUR, PSUR, PBRER) and development risk management plans (RMP)

●Led 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, and the other stakeholders

●Provided guidance and medical support to the safety scientists in charge of case processing, without a direct reporting line

CHARIS ASSOCIATES - SHERIDAN. WY Sep 2018 – Aug 2019

Pharmacovigilance Scientist

Key Contribution:

●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)

Diffusion Pharmaceuticals - Charlottesville, VA Jun 2017 – Jul 2018

Drug Safety Scientist

Key Contribution:

●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 study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, 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, Clinical Research Organizations, 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

Humanity First AMC Center - Chicago, IL Jun 2017 – Mar 2019

Medical Officer (Volunteer part Time)

Key Contribution:

•Documented patient progress and care to communicate information to other healthcare providers and ensure an accurate record of activity in compliance with established regulations

•Exhibited expert knowledge of policies, procedures, ethical standards, and laws regarding the delivery of medical care

•Strictly maintained the confidentiality of patients, families, colleagues, and any sensitive situations

•Performed physical examinations, diagnostic tests, and other procedures to diagnose illness and disease

•Provided primary care services to patients of all ages, and educated patients about their conditions and treatment plans

•Ordered diagnostic tests and lab work to aid in the diagnosis of disease, and referred patients to specialists when appropriate

•Worked in different settings from the medical unit to outpatient care, from admissions to discharge, and caring for the patients

•Counseled patients on health maintenance topics such as diet, exercise, stress management, and smoking cessation

University Of Lagos Teaching Hospital - Lagos, NG Nov 2016 – May 2017

Medical Officer (Tropical Medicine)

Key Contribution:

●Contributed clinical expertise to patient care and guided junior physicians

●Ensured the highest standards in patient care are maintained

●Verified complex diagnoses and facilitated treatment plans

●Kept informed on advancements in the field and contributed to medical research programs

●Ensured compliance with healthcare regulations and safety standards

●Reported to senior management, as well as liaising between administrative and medical staff

Accelerated Rehab and Pain Management - Parsippany, NJ Oct 2011 – Sep 2014

Senior Medical Intern

Key Contribution:

•Recorded provisional diagnosis, suggested primary investigations, and treatment plan provided that the treatment plan was discussed and approved by all team members

•Obtained results of all ordered investigations, documented complications that occurred and planned discharge and follow-up

•Carefully analyzed test results and information gathered during examinations to properly diagnose illnesses and diseases

•Obtained medical history and made an initial physical examination of patients, documented that on the patient’s file

•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

Bailey Outpatient Medical Services - Bronx, NY Oct 2010 - Sep 2011

Senior Medical Intern

Key Contribution:

•Obtained medical history and made an initial physical examination of patients, documented that on the patient’s file

•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

EDUCATION

Spartan Health Sciences University, Vieux Fort, St. Lucia

Doctor Of Medicine, MD

University of Lagos Teaching Hospital, Lagos, NG

Diploma, Tropical Medicine

Olive-Harvey College, Chicago, IL

Associate Of Science Applied Science

Olive-Harvey College, Chicago, IL

Certificate in Computer Information System

OTHER SKILLS / INTEREST

● Language: Fluent in English, Urdu / Hindi, Greek, Yoruba.

Moderately communicate, read and write in Arabic.

Limited knowledge of French.

● Travel Interest: lived in several countries, and willing to travel.

● REFERENCES

Available upon request

Contact this candidate