Global Pharmacovigilance Operations Contractor
2 months ago
Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022)
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.
#LI-Onsite
Vir Biotechnology ("Vir") is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, Inc., participates in E-Verify.
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