Buckeye Global · 18 hours ago
Drug Safety Specialist
United States
Contract
Remote
Senior Level
$43/hr - $48/hr
5+ years expBuckeye Global is seeking a Drug Safety Specialist to provide expertise in ensuring quality documentation of safety data, particularly serious adverse events. The role involves oversight of drug safety study operational activities from start-up to close-out, collaborating with various departments to manage safety data.
Information TechnologyIT InfrastructureStaffing Agency
Hiring Manager
Avinash Verma
Responsibilities
Processing and assessing SAEs from receipt at client to case closure in the Argus database, including query generation, narrative, and ASE writing
MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization
Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician
Scheduling submissions of expedited safety reports in ARGUS as needed
Training of new safety staff on Argus and case processing
Collaborating with other client departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data
Performing Safety Study Lead activities including:
Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician
Development of study specific safety management plan from client Drug Safety template
Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
Perform SAE reconciliation, as required by safety management plan
Additional duties and responsibilities as required
Qualification
Required
End-to-end study operations experience (start-up to close-out)
Case processing, electronic submissions, intake processes
Clinical Study Operations, Clinical Operations, and Clinical Trials (Study Operations is a must)
Pharmacovigilance, study & safety protocols
Safety/clinical trial databases
CRO/site interaction, study meetings
EDC systems (RAVE, Inform, Veeva)
UAT experience
PV vendor management
Review of study protocols and participation on IND Annual Reports in support of the Drug Safety Physician
Development and review of study specific safety management plan from client Drug Safety template
Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
SAE reconciliation
Query management
Vendor/CRO management
Study start-up to close out activities
Processing and assessing SAEs from receipt at client to case closure in the Argus database, including query generation, narrative, and ASE writing
MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization
Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician
Scheduling submissions of expedited safety reports in ARGUS as needed
Training of new safety staff on Argus and case processing
Collaborating with other client departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data
Performing Safety Study Lead activities including: Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician
Development of study specific safety management plan from client Drug Safety template
Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
Perform SAE reconciliation, as required by safety management plan
Additional duties and responsibilities as required
BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or, MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or, PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience
May require certification in assigned area
Preferred
Experience in Biotech/Pharmaceutical industry and/or in oncology
Experience using Argus safety database
Clinical trial and spontaneous adverse event processing experience
Company
Buckeye Global
Buckeye Global is a niche Staffing firm supporting Range of Industries across Multiple Categories.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase