09/06/2022 updated
100 % available
Pharmacovigilance and Clinical Trial Management Consultant
wixom, USA
USA
Medical DoctorAuditingClinical ResearchClinical Research CoordinationClinical Trial Management SystemsConstruction ManagementData QualityPharmacovigilanceMicrosoft OfficeSafety PrinciplesContract Reviews
I have experience in pharmacovigilance and clinical trial management.
Pharmacovigilance
Document creation, review, and finalization
ICSR/Safety Variation Monitoring
PSMF creation and review
Contracts and agreements review
Audit and inspection readiness
Clinical Trial Management
Protocol Writing
Local site management
Clinical Research Coordinator and Clinical Research Associate services
Source Data Review and verification
Regulatory and IRB compliance
Vendor and budget review and selection
Site visits ie initiation, monitoring, closeouts
Pharmacovigilance
Document creation, review, and finalization
ICSR/Safety Variation Monitoring
PSMF creation and review
Contracts and agreements review
Audit and inspection readiness
Clinical Trial Management
Protocol Writing
Local site management
Clinical Research Coordinator and Clinical Research Associate services
Source Data Review and verification
Regulatory and IRB compliance
Vendor and budget review and selection
Site visits ie initiation, monitoring, closeouts
Experience
Professional experience5 - 10 years
Languages
EnglishNative speaker
Project history
* Worked with doctors and medical researchers throughout the US to assist with research
projects and clinical trials from phase 1 - 4.
* Worked with sponsors to create abstracts, study designs, protocols, and final reports for
publication.
* Assisted in data collection, sorting, and documentation of clinical information within the
constraints of the project.
* Managed resources, budgets, and timelines to ensure that all undertaken projects could be
managed effectively and efficiently.
* Work with CROs, third party vendors, and field CRAs to ensure compliance with study
protocol.
* Managed projects simultaneously with multiple teams ranging from 2 - 10 contractors to
ensure the customer's milestones and project deliveries were met.
projects and clinical trials from phase 1 - 4.
* Worked with sponsors to create abstracts, study designs, protocols, and final reports for
publication.
* Assisted in data collection, sorting, and documentation of clinical information within the
constraints of the project.
* Managed resources, budgets, and timelines to ensure that all undertaken projects could be
managed effectively and efficiently.
* Work with CROs, third party vendors, and field CRAs to ensure compliance with study
protocol.
* Managed projects simultaneously with multiple teams ranging from 2 - 10 contractors to
ensure the customer's milestones and project deliveries were met.
* Responsible for creating relationships with doctors throughout the region, to stimulate
recommendations for home healthcare services.
* Created marketing campaigns to expand the company's presence throughout the
community and increase brand recognition.
* Recruited quality employees to perform medical services for patients.
recommendations for home healthcare services.
* Created marketing campaigns to expand the company's presence throughout the
community and increase brand recognition.
* Recruited quality employees to perform medical services for patients.
* Responsible for checking, dispensing and educating patients on their medications.
* Produced custom formulations of compound creams, and capsules for patients with atypical
diseases and treatments.
* Increased capacity of production of unique therapies by 10% by implementing Kaizen
processes to the laboratory environment.
* Produced custom formulations of compound creams, and capsules for patients with atypical
diseases and treatments.
* Increased capacity of production of unique therapies by 10% by implementing Kaizen
processes to the laboratory environment.