Senior Drug Safety Associate resume example

Duties:

• Responsible for day-to-day drug safety operations, including the management of in-house Serious Adverse Event (SAE) case processing and external pharmacovigilance vendors
• Oversaw the hiring, training and management of drug safety operations staff
• Acted as the safety database (ARISg) administrator working with ARISg to execute system upgrades, conduct user administration testing (UAT) and review data outputs and system reports
• Responsible for the drafting and/or review of SAE case narratives, SUSAR reports (e.g. CIOMS/MedWatch), investigational product Reference Safety Information (RSI)
  
• Served as the drug safety/pharmacovigilance subject matter expert, providing drug safety guidance for product and/or study specific audits
• Developed and maintained drug safety SOPs/job aids/work instructions, safety management plans, company SAE report form template
• Assisted in the review of annual regulatory safety information (e.g. DSUR, Investigator's Brochure) as well as assist with any ad-hoc regulatory questions specific to drug safety
• Closely collaborated with Data Management on SAE reconciliation issues

Key Accomplishments:

•  Developed the entire drug safety department at OncoGenex including the implementation of new processes, procedures, safety database and structuring the Pharmacovigilance Master Files.
• Promoted into Senior Drug Safety Associate
  

Duties:

• Managed and maintained Trial Master Files for OGX study products      
• Managed Drug Safety case processing and developed CIOMS and MedWatch reports for submission to regulatory authorities and distribution to CROs       
• Oversaw, managed and presented at 2 domestic and 4 international Investigator Meetings for phase II/III global clinical trials
• Managed country-specific and site-specific informed consent form development during the study start-up process for global phase II/III clinical trials
• Assisted in review of study documentation (e.g. protocol amendments, consent form template, pharmacy manual, study management plan, etc.)
  
• Managed initial site shipments of drug working closely with drug distribution vendor
  
• Assisted with quality checks of clinical database (e.g. Merge) during study start up

Key Accomplishments:

• Successfully managed 6 investigator meetings, which were executed on time and on budget
• Promoted to Drug Safety Associate
  

Duties:

• Developed, managed and maintained clinical study Trial Master Files
• Assisted with monitoring of clinical research data and the creation of data queries
• Helped edit and develop Institutional Review Board study submission documentation
• Created and managed a myriad of regulatory trackers
• Acted as data documentation coordinator for preclinical studies
• Conducted QC of study documentation (e.g. clinical study reports, study protocols and supporting documents)
• Provided general support for Clinical R&D team
  

Duties:

• Voting board member for the Social/Behavioral/Educational (SBE) Research Panel
• Alternative coordinator for Biomedical and SBE Research Panel
• Lead reviewer for all Expedited and Exempt Behavioral/Social/Marketing/Educational human subject research protocols
• Developed new, and edited existing internal and external guidance documentation to be used by staff, student researchers and faculty
• Edited and maintained all standard university informed consent form templates for human subject research
• Assisted with the revision of IRB Standard Operating Procedures (SOPs)
• Assisted in QA of active research files
• Educated faculty and student researchers on human subjects research regulations

Duties:

• Voting board member for the Behavioral/Social/Educational Panel and alternative voting member for the Biomedical Panel
• Responsible for the review of all expedited and exempt Panel A protocols
• Assisted in refining the IRB’s current Standard Operating Procedures
  
• Coordinated Full Board meetings and transcribed the monthly meeting minutes
• Processed all approval documentation and research communication associated with Panel A protocols

Key Accomplishments:

Overhauled the review process and improved the review turnaround time from 6 weeks to 24-48 hours for all expedited and exempt research protocols

Promoted into IRB Administrative Review Coordinator

Duties:

• Oversaw research studies (Phases II-IV), acting as the liaison between the sponsor and the IRB
• Provided continual support to the sponsoring pharmaceutical company and/or contract research organization (CRO) throughout the duration of a research study
•  Analyzed and prepared all sponsor submitted study materials for Board review
• Aided and educated sponsoring pharmaceutical companies/CROs and investigational research sites on the policies and procedures instituted by the IRB
• Maintainence of study files
• Resolved complex study matters and ensured regulatory compliance with FDA regulations
• Worked and collaborated with numerous internal departments to make certain all matters involving the studies and their sites are cared for at the time of inquiry

Key Accomplishments:

Acted as the dedicated Study Manager for Quorum Review’s largest client and was acknowledged as being responsible for the fastest study start-up in the client’s history

Duties:

• Prepared initial site documentation for Board review
• Assisted investigational research sites with questions and concerns with regards to initial site specific submissions
• Provided study coordinators and principal investigators with guidance about possible protocol deviations or serious adverse event reporting