GERARD ELONGE-FOBIA, MD

Katy, TX

480-***-****

ad4kbb@r.postjobfree.com

HIGHLIGHT OF SKILLS

Global Drug Safety Physician-Scientist with 10 years of experience in the biopharmaceutical and biomedical research industry, and 20 years of experience in general clinical care. Direct industry experience across all phases of clinical development and post-marketing. Responsible for authoring and review of aggregate reports, medical review of ICSRs from clinical trials and post- marketed products, preparing responses to health authority inquiries, and registration. Result- oriented, excellent attention to detail, strong analytical skills, ability to work on multiple projects in parallel, excellent written and communication skills, and people management. Educational Commission for Foreign Medical Graduates (ECFMG) certified. Therapeutic Areas

Oncology Immunology Infectious Diseases Neurology Psychiatry Technical Aptitude

Data mining and exploratory analyses (Spotfire and MedDRA) Labeling tools (DocLabel) Microsoft Office Suite (Excel, PowerPoint, and Word) Safety databases (Argus and ArisG) PHARMA EXPERIENCE

Sumitomo Pharma America, Inc. (formerly Sunovion Pharmaceuticals, Inc.) Medical Director / Drug Safety Physician

July 2021 – Present

Accountable for input and oversight of ongoing safety surveillance, benefit/risk profile and risk management activities for assigned products through the product lifecycle. This includes medical review of clinical trial and post-marketing ICSRs; Adverse Event Reports

(AEs), Serious Adverse Event Reports (SAEs), and Product Complaints (PCs).

Lead safety signal evaluation for assigned development and marketed products, working closely with safety scientists to ensure early identification of safety signals and proper escalation through safety governance, including Safety Management Team (SMT), Therapeutic Area Safety Committee (TASC), and Executive Safety Committee (ESC).

Contribute to medical oversight of clinical trials, individual safety and laboratory data.

Generate safety queries, evaluate safety data, and contribute/author safety sections as a medical safety subject matter expert (SME) on behalf of Pharmacovigilance and Risk Management (PVRM) for regulatory safety documents. These include: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports

(CSR), Investigator’s Brochures (IB), Investigator communications (Dear Health Care Provider letters - DHCP), Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports), Company Core Data Sheets (CCDS), and locally approved labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics

(SmPC), and Canadian Product Monograph (PM).

Analyze aggregate data from clinical trials and spontaneous post–marketing sources

(healthcare providers, patients, caregivers, literature, partners, and vendors/contractors).

Contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, inspection/audit readiness, and direct participation in partner audits, and authority inspections.

Contribute to authoring sections of the ISS and ISE for an sNDA.

Serve as liaison between the PV team and ICSR vendor and chairs PV-Vendor meetings.

Manage 1 PV consultant and 1 PV Scientist

Merck

Medical Director / Medical Safety Review Physician January 2017 – July 2021

Performed medical assessment of individual cases based on clinically relevant information and the known safety profile of investigational medicinal and marketed products.

Assessed the expectedness of reported events against various reference safety information sources and provided causality assessment and company statement for regulatory reporting requirements.

Determined the need for expedited reporting to regulatory agencies, performed analysis of similar events, and participated in quality review of ICSRs from other Medical Safety Reviewer (MSR) Physicians.

Reviewed and analyzed safety data from clinical trials and regulatory agencies to predict/establish the safety profile of developmental and marketed products.

Led and/or participated in cross-functional projects as the MSR physician subject matter expert contributing to continuous process improvement of ICSR assessments and consult with the Clinical Director for the trial and with the Clinical Safety and Risk Management

(CSRM) Physician, as needed, for cases requiring additional clinical or safety subject matter expertise.

KAI Research Inc.

Medical and Device Information Specialist

October 2016 – January 2017

Prepared expedited and periodic case reports for marketed drugs (NDS/ANDAs) for submission to the FDA.

Reviewed medical and scientific literature and bibliographic sources for reports of adverse events for signal identification

Technical Resources International, Inc.

Safety and Pharmacovigilance Specialist

June 2014 – October 2016

Processed Serious Adverse Events (SAEs)/Expedited Adverse Events (EAEs) transmitted to the National Institute of Health (NIH) groups including the National Cancer Institute (NCI) for the Cancer Treatment Evaluation Program (CTEP), the Division of Microbiology and Infectious Diseases (DMAIDS), and the Division of AIDS (DAIDS) sponsored clinical trials.

Reviewed ICSRs for validity, clarity, consistency, seriousness, expectedness, and relatedness, and performed case evaluation of adverse event reports to gather required medical information and source documentation from clinical trial sites. Everest College, Institute, and University

Faculty Member

January 2013 – October 2014

Developed curriculum and syllabi; monitored, evaluated, and assessed students’ progress through observation, tests, and examinations in theory and practice for nursing and medical assistant students.

Ministry of Public Health, Cameroon

Medical Officer, Oku District Hospital

July 2005 – October 2012

Provided senior clinical leadership, fostered superior quality patient care, developed strategic goals and direction, and assured the timely recruitment and retention of the medical staff at the District Hospital.

Offered comprehensive medical and surgical care to patients in both in-patient and out- patient settings.

Managed district hospital personnel, resources, and projects.

Provided community education and counseling.

EDUCATION

Institute of Tropical Medicine, Antwerp, Belgium

Global Management of HIV/AIDS Certificate, 2015

Clinical Research Academy of America

Drug Safety and Pharmacovigilance Certificate, 2013 National Board of Medical Examiners

Educational Commission for Foreign Medical Graduates (E.C.F.M.G) Certification, 2010 University of Yaoundé I

Doctor of Medicine Diploma, 2005

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