Dr FATOU BIN NDURE, MD
PINEVILLE,North Carolina
Summary
Dedicated pharmacovigilance professional with years of experience in medical evaluation and assesment, narrative writing, case processing (Argus and safety easy) , medDRA Coding, aggregate reporting, signal detection review and benefit-Risk Analysis and risk minimization planning.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Lead, Drug Safety Physician
Biorasi
Charlotte
01.2022 - Current
- Determining sponsor causality for serious adverse events.
- Safety Manager for different trials including neurology trials, Urology, gynecological, oncological trials etc.
- Drafting Safety Management Plans and Medical Monitoring Plans for different trials
- Reviewing narratives, lab listing review
- Training staff on relevant safety topics
- Drafting and reviewing company Standard Operating (SOPs), drafting Safety Adjudication panel and DSMB charter
- Reviewing Protocols/Protocol Synopsis for sponsors
- Safety submissions to regulatory and ethics committee
- Patient eligibility review/ Pre-enrollment review
- Clinical data/safety listing review and query management (From generation to resolution)
- Leading safety meetings, drafting minutes for meetings, and preparing compliance reports.
- Reviewing codes from EDCs, possessing proficiency with various electronic databases.
- Attending Kick off meetings and DSMB metetings
Country Coordinator
Marken
Pineville, North Carolina
08.2021 - 01.2022
- Collaborated with study sites and investigators to carry out efficient and fully compliant research trials.
- Kept patient care protocols and clinical trial operations in compliance.
- Analyzed issues and recommended corrective actions to improve final results as well as created NTFs, CAPAs etc.
- Spearheaded trials from initial visits and meetings through completion.
- Collaborated with project teams to contribute research methods for trials.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Participated in audit preparation as well as regulatory activities submissions
- Performed quality control inspections at customer sites to determine alignment with safety regulations.
- Trained nurses in proper equipment use and product testing procedures.
Phamacovigilance Specialist
Think I
Chralotte , NC
08.2018 - 08.2021
- Serve as safety aggregate reports deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.
- Drafted and finalize aggregate reports.
- Communicating with other groups within the Safety lifecycle, such as Regulatory Affairs, Medical Writing, Clinical Research, Quality, and Information Technology, as needed.
- Served as the interface between the global project lead and the working team.
- Spearheaded meetings at different levels of trials and coordinated activities required to implement changes.
- Performing quality check of listings for PSUR, DSUR and PADER reports.
- Review all periodic safety reports listings and tabulations.
- Signal detection review including identification and interpreting of safety signals.
- Assist with training/mentoring newly hired safety associate.
- Quality Review Check of case processing and narratives for members of the team.
- Argus case processing and medical review.
- MedDRA and WHO DD coding using different EDCs.
Clinical Research
Javara/ Tryon Medical Partners
Charlotte, NC
09.2017 - 03.2018
- Recruited patients for research studies
- Managed volunteers the studies.
- Kept patient care protocols and clinical trial operations in compliance.
- Educated clinical study participant and addressed concerns.
- Managed trial specifics EDC and CRIO.
- Resolved queries.
Clinical Research Associate
Carolinas Research Center
Charlotte, NC
01.2017 - 09.2017
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Performed pre-study, closeout and interim visits to check on study activities.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
- Monitored site activities and sent follow-up letters to participants.
- Evaluated proof of eligibility and consent for participants.
Assistant Physician
Shifa Clinic
Charlotte , NC
02.2016 - 01.2017
- Conducted patient interviews to gather health history, vital signs and information about current medical issues.
- Input details about patient histories, physical examinations, medications and other information into physical or electronic charts.
- Scheduled appointments for patients via phone and in person.
- Clinical work- Including: blood draw, allergy test, breathing treatment, spirometry, EKG, Tm flow, giving injections etcs....
- Running Labs- Including: Processing blood and urine samples, strep test, py test etc...ts
Physician
Edward Francis Small Teaching Hospital
Banjul, The Gambia
01.2011 - 12.2015
- Performed minor Medical procedures and assisted in major surgical procedures Performed lab work.
- Documented patient's visit.
- Determined and prescribed medication.
- Counseled patients.
- Performed blood draw.
Clinical Research
British Medical Research Council
Banjul, The Gambia
01.2011 - 12.2014
- Recruited volunteers for studies.
- Assessing ADR and writing medical reviews.
- Kept patient care protocols and clinical trial operations in compliance.
- Managed clinical research trials.
- Collected, processed and delivered specimens from trial participants.
- Educated clinical study participant and addressed concerns.
Education
USMLE -
ECFMG Certification
M.D. - Medicine
University of The Gambia Medical School
2011
Phamacovigilance/ Drug Safety And Medical Review
Cliniminds Academy
07.2020
Clinical Research Coordinator
Clinical Research Fastrack
2019
IT Diploma - Elementary, Intermediate and Advanced
Quantum Net Institute of Technology
2010
Clinical Internship
Singleton Hospital
Swansea, UK2009
Skills
- Case processing in Safety easy and Argus
- Medical Assesmnet
- MedDRA Coding
- Narrative writing
- Excellent Medical assessment
- Medical evaluation of ICSR
- Aggregate reporting
- Signal detection
- Risk management
- PV audits and documentation
- Risk management and Mitigation Strategies in the US
Certification
- Clinical Research
- BLS certified: Adult and Child
- GCP Certified
- Medical Degree (MBChB), University of The Gambia Medical School
- ECFMG Certification (United States Medical Licensing Examination-USMLE)
- Medical Assistant- ARMA
- Emergency Triage Assessment and Treatment, WHO
- Basic urology skills, The British Association of Urological Surgeons
- Excellence in Pediatrics, European Accreditation council for Continuing Medical Education
- Emergency skills in reducing Neonatal and Perinatal mortality, WHO, MRC and Imperial College- London
- Clinical Internship, Singleton Hospital- UK
Timeline
Lead, Drug Safety Physician
Biorasi
01.2022 - Current
Country Coordinator
Marken
08.2021 - 01.2022
Phamacovigilance Specialist
Think I
08.2018 - 08.2021
Clinical Research
Javara/ Tryon Medical Partners
09.2017 - 03.2018
Clinical Research Associate
Carolinas Research Center
01.2017 - 09.2017
Assistant Physician
Shifa Clinic
02.2016 - 01.2017
Physician
Edward Francis Small Teaching Hospital
01.2011 - 12.2015
Clinical Research
British Medical Research Council
01.2011 - 12.2014
USMLE -
ECFMG Certification
M.D. - Medicine
University of The Gambia Medical School
Phamacovigilance/ Drug Safety And Medical Review
Cliniminds Academy
Clinical Research Coordinator
Clinical Research Fastrack
IT Diploma - Elementary, Intermediate and Advanced
Quantum Net Institute of Technology
Clinical Internship
Singleton Hospital
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