Job Summary:
Vir Biotechnology is looking for a Pharmacovigilance Operations Contractor to help support the global PV Operations team.
This role is located in San Francisco and will report to the Director of PVRM Operations.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Support the daily functioning of the Pharmacovigilance Operations Department.
- Assist with compliance with standard operating procedures (SOPs), regulatory safety, and pharmacovigilance in compliance with US and global regulations.
- Responsible for operational tasks related to electronic Trial Master File documents, including quality review, organization, maintenance, and storage following study procedures.
- Help with Pharmacovigilance mailbox (i.e. ensure all emails are processed, identify requests, ensure all emails are prioritized and organized as well as follow-up on outstanding deliverables).
- Perform quality review of individual case safety reports (ICSR)
- Help track submissions of ICSRs and aggregate safety reports (i.e. line listings, DSURs, PADERs, PSURs/PBRERs, IND Annual Reports, PADERs, etc.).
- Communicate with pharmacovigilance and clinical vendors for all pharmacovigilance operations activities.
- Participate in set-up of new clinical trials, including development of study-specific Safety Management Plans and Forms.
- Assist in writing and maintenance of Global PVRM and safety related cross functional SOPs and work instructions
- Manage review of Safety Regulatory Intelligence within Global PVRM
- Help with other activities and special projects
QUALIFICATIONS AND EXPERIENCE:
- BS/MS/RN/RPh and with 5+ years of experience in drug safety/pharmacovigilance operations with broad exposure to Trial Master File (TMF) and ICSR activities.
- Working knowledge of domestic and international adverse event reporting regulations (ICH, EMA GPV, GCP, FDA etc.)
- Experience in case management and case processing activities.
- Experience using ARGUS or other safety databases.
- Experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications.
- Experience writing SOPs
- This is a Hybrid role and will require you to spend a certain number of days in our San Francisco office each week
The expected salary range for this position is $55.00 to 78.00/Hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
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