Residencia Regina

#94 Xavierville avenue, Loyola Heights, Quezon City

+639531223757/ +639190049664
jamesbelgiratamayormtmd@gmail.com

James Belgira Tamayo

Competent, hard-working, result driven and strong dynamic
physician with 9-years of combined general and internal
medicine clinical and hospital experience, 6-years of combined
corporate experience with managerial and supervisor role in
clinical research trials, pharmacovigilance, medical scientific
liaison and regulatory affairs.
Able to demonstrate and apply expertise in clinical laboratory
science with strong foundation and background in internal
medicine during my previous role and projects.
Education and training: Core Competency
December 2023 to Present
San Mateo Medical Center & Pasig Doctors
Medical Center (Internal Medicine Junior
Consultant)
 Assisted Senior consultants in handling admitted
patients. Decreased and prevented mortality in severe
and complex cases admitted at the intensive care unit.
 Directed and supervised newly minted physicians during
their tour of duty in the emergency room, ward and acute
intensive care unit.

 Spearheaded and designed programs, protocols and led

January 2018 – January 2020
Internal Medicine
Mary Johnston Hospital
June 2007 – March 2013
Doctor of Medicine
San Beda University College of
Medicine
June 2002 – March 2006
B.S. Medical Technology
Centro Escolar University
cross-functional team of professionals for processes and
 Creativity
clinical practice guidelines to follow for our patients.
 Leadership
 Organization  Listened, advised and provided support top resolve any
 Problem solving healthcare service related concerns and problems.
 Teamwork  Pro-actively guides, track, organize and over saw
 Signal Detection
medicine interns, nursing interns, medtech interns and
 Literature Review and Journal
other allied health care courses to maximize their
Appraisal
learning in hospital setting.
 Medical Writing
 Project management  Oversees and supports Hemodialysis unit, Heart station
and Neurodiagnostic procedures ( CT-scan, MRI, EEG).
January 2022 to November 2023
Johnson & Johnson
Global Safety Surveillance Physician Manager
 Exceed and excelled handling ALL of the products under
immunology, infectious disease and vaccines.
 Delivered solutions and resolved problems concerning
revisions on Clinical core data sheet, investigator
brochures, watchlists and submitted CAPA to FDA, EU
authorities and MHRA.
 Generated and accomplished alignment of product’s IB
update, Pbrer, Product safety review, quarterly report with
the Medical safety officer.
 Saved and prevented over 60 SUSAR’s report.
 Analyzed potential signals and identified true signal from
potential signals under the products I have handled.
 Provided medical review and analysis for clinical trial
serious adverse events, marketed products ICSR and
periodic safety reports (e.g. PBRER, PSUR, DSUR), as
well as other client deliverables (e.g. labeling
reconciliation documents, CTD modules, REMS, RMP,
Signal detection reports and CSR).
 Maintained understanding of methods for recording time
spent on project and administrative tasks, expense
submissions and travel.
 Ensured and oversaw that tasks delegated to PVG are
properly executed. Adheres to applicable regulations and
ICH guidelines regarding clinical trials, regulatory
documents, and safety issues. Adheres to client
SOPs/directives and project specific WPDs for assigned
projects. Adheres to PPD’s corporate policies and
SOPs/WPDs.
 Provided medical consultation suggestions and expertise
to team members and swiftly answered all project/study
related medical questions. Communicated clearly with
associates and clients, maintaining an open line of
communication to ensure all procedures are followed
appropriately.
 Provided safety reporting training on assigned
projects/studies, as requested.
 Medically reviewed adverse event and serious adverse
event data from all sources (solicited, spontaneous,
literature, etc) as contracted.
 Provided medical review of adverse events of special
interest, serious adverse events and clinical outcomes
events reported in Clinical Trials.
 Performed data review as specified in the client contract
and data validation manual including review of coding
listings and/or full safety data to assess for potential safety
concerns.
 Completed online course of DIA pharmacovigilance with
Certification.
 Assisted in writing (interpretation of safety data) and/or
review of CSR, IND/NDA report, ICSR, signal
detection reports, periodic reports, RMP, REMS, CTD
modules, etc. to ensure that the medical content is
accurate and complete.
 Managed signal detection activities, scientifically
reviewed periodic safety reports, contributed to label
updates, supported dossier maintenance and risk
management activities.
 Served as a consultant and spokesperson for the
functional area or as an external spokesperson for the
organization on highly significant matters. Created
formal networks with key decision makers.
March 2021 to October 2021
IQVIA
Lead Clinical Research Associate
• Performed site monitoring visits (selection, initiation,
monitoring and close-out visits) in accordance with
contracted scope of work and regulatory requirements,
i.e., Good Clinical Practice (GCP) and International
Conference on Harmonization (ICH) guidelines
• Collaborated with sites to adapt, drive, and track subject
recruitment plan in line with project needs to enhance
predictability.
• Administered and spearheaded protocol and related
study training to assigned sites and established regular
lines of communication with sites to manage ongoing
project expectations and issues.
• Evaluated the quality and integrity of study site practices
related to the proper conduct of the protocol and
adherence to applicable regulations. Identified and
escalated quality issues to swiftly resolve future
problems.
• Managed the progress of assigned studies by tracking
regulatory submissions and approvals, recruitment and
enrollment, case report form (CRF) completion and
submission, and data query generation and resolution.
Supported start-up phase until site process has full in
control and manage implementation of the clinical trial
protocol.
• Ensured copies/originals (as required) site documents
are available for filing in the Trial Master File (TMF)
and verified that the Investigator's Site File (ISF) is
maintained in accordance with GCP and local regulatory
requirements.
• Created and maintained appropriate documentation
regarding site management, monitoring visit findings
and action plans by submitting regular visit reports,
generating follow-up letters and other required study
documentation.
  Collaborated and liaised with study team members for project
execution support as appropriate.
 Participated in supporting development of project subject
recruitment plan on a per site basis, site financial management
according to executed clinical trial agreement and retrieve
invoices according to local requirement.

International Clinical Trials and Research Participations:

January 2018 to October 2021
1. Mary Johnston
Multicenter, Hospital
randomized, Clinicalparallel
double-blind, Research
group Division
clinical study
of S-649266
Senior Compared with Meropenem for the Treatment of
Sub- Investigator
Hospital-acquired Bacterial Pneumonia or Healthcare-Ventillator-
associated Bacterial Pathogens (27-March-2017 up to 2020).
2. A  PhaseFunctional role as an alternative
3, Randomized, site Single
Double-blind, Point Comparator-
Active of Contact
(SPOC)
Controlled other than
Clinical Trialthetoprincipal
Study theinvestigator in assigned studies
safety, Tolerability, and
Efficacyforofinvestigative sites, RSU Relebactam
Imipenem/Cilastatin/ Team Lead, Clinical Operations,
(MK-7655A) Versus
Feasibility, Site Identification,
Piperacillin/Tazobactam in subjects with Project Leadership andBacterial
Hospital-Acquired GICS.
Ensure
Pneumonia adherence2018
(September to standard operating procedures (SOPs),
up to 2020).
work instructions
3. A Multi-national Phase(WIs), quality of designated
3, Randomized, deliverables
Double-Blind, and
Active
to project timelines.Clinical Trial to Study the Safety,
Comparator-Controlled
 Performed
Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam
regulatory, start-up and maintenance activities Versus
Piperacillin/Tazobactam
according to applicable in Subjects with Hospital
regulations, SOPs andAcquired
work Bacterial
or Ventilator- Associated Bacterial Pneumonia (May 2019 up to
instructions.
2020).
 Prepared site regulatory documents, reviewing for completeness
4. A phase and2b Randomized Blinded Study to Evaluate SYN023
accuracy.
Compared to Human Rabies Immune Globulin in Post Exposure
 Reviewed, prepared and negotiated site contracts and budgets
Prophylaxis of Rabies in Adult with different Rabies exposure risks.
with CRO if applicable.
(September 2019 up to present).
 Ensured accurate
5. Acute Generalized completionPustulosis
Exanthematous and maintenance
(AGEP)ofsecondary
internal to
systems,
Ceftriaxone. databases
Poster and tracking
Presentation Worldtools with project specific
Dermatologist Conference
information.
Italy 2019.
 Ensured
6. Infection Control contracts are fully executed,
Transmission at Mary regulatory
Johnston documents
Hospital: and A
approvals
descriptive are granted,
randomized IP Release
sampling authorized
of Medical and specific
Chart Cases, as a
project
potential intradeliverables are completed.
hospital carrier of hospital acquired infection,
 Reviewed
Isolation and identification
and provided of opportunistic and pathogenic
feedback to principal species
investigator, CRA
and a randomized
and CRO regardingcontrol trial of identifying
management on sitea performance
readily available and
metrics.
cost
 effective
Reviewed, disinfecting
establishedagent. 1st placer
and agree MJH planning
on project Interdepartmental
and
Research contest
project 2020. 2nd
timelines. placeroverall
Ensured World project efficiency and
Academy of Science
adherence and Technology
to project Conference
timelines. Ensured (WASET.ORG)
monitoring measures
International Research
are in place and implement contingency plan as needed.
Conference.
 ContributedDecember 2021.
to the collection, interpretation, analysis and
7. A Randomized, Double-blind, Placebo Controlled phase 3 Study to
dissemination of accurate regulatory intelligence to support
assess the efficacy and safety of Ad26.Cov2.S for the Prevention of
assigned studies and wider company, as required.
SARS-CoV-2-mediated COVID-19 in Adults Aged 18 years and

Older. Assisted in pre-award activities including bid defenses,
8. A Global,proposals and oversights
Multi-center, of the scope Double-blind,
Randomized, of work at country level.
Placebo
 Provided
controlled Phase input into contract
III Clinical trial toand budgetthe
evaluate template development.
protective efficacy
and safety
Facilitated and supported
of Influenza virus vectorimportation
Covid-19activities.
Vaccine for intranasal
 (DelNS1-2019-nCoV-RBD-OPT1)
spray Engaged direct contact with sponsors in on
Adults Aged
specific 18 years
initiatives.
and older.
 Took the role of Local Regulatory, Ethics and Contract Expert
9. ZZA71149 A Randomized,
and reviewer of ICF. Double-blind, Placebo controlled, Phase
III Study to Evaluate the efficacy and Safety of Proxalutamide
 Led, supervised, functioned as a mentor and prepare and deliver
(GT0918) in Hospitalized COVID-19 Subjects.
country-specific training, for less experienced staff.
10. All clinical trials under Immunology, Infectious Disease and

VaccinesParticipate
during my intenure
feasibility and/or and
at Johnson site Johnson.
identification activities and
assisted
(27 clinical in site monitoring visits.
trials)

References:

 Available upon request