Afolarin Ishola

Drug: Crenolab (ARO-013) Phase 3 clinical trial for refractory AML with mutation in the FLT3

• Implemented safety monitoring strategy for randomized, multi-center, open label, two arm, phase III neo-adjuvant study by evaluating activity, efficacy, safety and pharmacokinetics of Crenolab (ARO-013) Phase 3 clinical trial for refractory AML with mutation in FLT3
• Review of clinical data for update submission to FDA and presentation at American Society of Clinical Oncology annual meeting
• Safety data review including data from clinical trials , literature review and post-approval reports.
• Collaborate with other safety scientist for safety surveillance activities and development of RMP.
• Medical Subject matter expert for clinical matters raised by collaborators , investigator, and strategic partners.
• Coordinate all activities related to review of data and presentation at different leadership forum.
• Provides medical evaluation of adverse event reports including AE, SAE and SUSAR
• Prepare case narrative for SAE reports and prepare MedWatch , CIOMs, PADER , PBRER, PSUR and other reports.
  Ensure implementation and execution of regulatory QMS documentation strategies.
• Provide general regulatory support for product development and supervise changes in protocols
• General clinical research and product support including preparation of IND safety reports, application safety updates and product labeling.

Drugs: Ustekinumab (Stelara), COVID-19 vaccine

• Monitoring of AE/SAEs & safety signals related to marketed products & clinical trials.
• Responsible for scheduled and ad hoc aggregate reports including PADER, PBRER and DSUR
• Managed general signal processing and medical case review in Argus 8.2.2
• Initiate/Conduct/Oversee searches of internal and external databases
• Contributed to the development and implementation of regulatory policies leading to accelerated product approval resulting in >50% time to market for the J&J vaccine
• Prepared and review regulatory documents including investigational new drugs (IND) and new drug applications (NDA)
• Developed Risk Management Plan (RMP) for validated signals
• General HEOR with focus on RWD/RWE, PRO, public health, and epidemiology
• Database searching, aggregate safety analysis and case reviews
• Project management and coordination of strategic safety documents
• Partners with stakeholders in coordinating global regulatory submissions and ensuring compliance with international regulatory requirement including ISO, CE and other country specific regulations
• Supports SMT deliverables as required.

Drug: SAR442168 Phase 2/3 clinical TrialUtilized MedDRA coding and ICD 10-DSM coding

• Expert Review of ICSRs, AEs, SAEs for both SAR and SUSAR
• Developing, Maintaining, Managing, and Optimizing RMP/REMS/PBRER
• Medical review of DSURs, PBRERs and Annual Reports
• Domestic and International Labeling following FDA and EU-MAA approval process
• Review of compliance with Drug Safety and Pharmacovigilance Regulations
• Member of FDA Advisory Committee and responding to FDA queries/audits
• Obtain, review, and process essential regulatory and administrative documents
• Conduct audit of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
• Created Company Core Data Sheet, Company Core Safety Information, Investigator BrochuresUnderstand project scope, budgets, and timelines; manage site level activities/communication to ensure project objectives, deliverables and timelines are met
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

Drug:ABX-1431 Phase 2/3 Clinical Trial

• Intended Usage:Tourette Syndrome in Adults, Multiple Sclerosis, and Immuno-oncology.Development and implementation of payer value proposition and access strategies
• Development of pre-marketing and post marketing access strategy with a compelling, scientific value report that highlights optimal benefit to the patients and a good return on investment to the company
• Signal case processing, analysis, ICSR generation and appropriate notification to regulatory agencies
• MEDRA coding and case processing in Argus 8.2.1
• Preparation of RMPS/REM based on case investigation finding
• Provide medical review for aggregate regulatory documents (PBRERs, PADERs and DSURs)
• Review emerging data from clinical studies for possible adverse event, outliers, and cofounder's
• Aggregate safety data analysis and report writing.

• Site study coordinator and maintenance of investigator file for assigned protocols
• Work with principal investigator (PI), in screening of study participants, conducting informed consent process as designated by the study protocol
• Work with PI on protocol submissions (internally sponsored and/or externally sponsored) to federal (FDA), international and/or institutional committees (e.g
• CTSRC and IRB) as applicable
• Performs data abstraction, collection, entry, clean-up to support the clinical research
• Regular data analysis with detailed data report to monitor study progression
• Prepares submission for all reportable events (e.g., adverse events, protocol variances, violations, etc.)
• Develops, maintains, and/or monitors case report forms and review with PI
• Ensures compliance with prescribed interventions and ensure protocol compliance
• Regular site visit as indicated by study protocol
• Provides data to the collaborating research organization (CRO) or study sponsor.

• Designing clinical study protocols using approved statistical analysis plans , ensuring randomness of sample and reduction of bias
• Data analysis using SAS protocols for analysis of disease pattern and hospital metrics.
• Review of data set and analysis of signal pattern in different communities use in implementation of study protocol.
• General statistical report writing, development of data Set from raw files using Program R and SAS
• Performance management (PM) model and continuous quality improvement (CQI) methods in analysis of data
• Medical writing, review of clinical trial, data analysis and writing of reports, etc.
• Active participation in ongoing hospital clinical research and drug trial/new treatment protocol reviews
• Literature review and research into possible drug interaction in clinical trial patient
• Review of data with principal investigators (PI) and other members of the clinical trial team

• Teamed with other physicians, specialists, and health care providers to provide well-rounded care for HIV , TB and other infectious disease
• Thoroughly examined patients and elicited medical history data to use in assessing health and identifying conditions.
• Teamed with other physicians, specialists, and health care providers to provide well-rounded care for HIV , TB and other infectious disease
• Thoroughly examined patients and elicited medical history data to use in assessing health and identifying conditions.
• Diagnosed and treated patients suffering from infectious disease
• Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants.

• Performed outpatient and inpatient care of medical and surgical patient with infectious disease
• General evaluation of patient's enrolling in clinical trial.
• Performed outpatient and inpatient care of medical and surgical patient with infectious disease.
• General evaluation of patient's enrolling in clinical trial
• Polio vaccine signal detection, investigation and reporting to pharmaceutical companies and/or NAFDAC ( FDA equivalent)