Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. 

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.

Job Summary:

Vir Biotechnology is looking for a Senior Manager, 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:

  • RN/PharmD or similar degree 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 SOP
  • This role is located in San Francisco at our corporate office

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 

Applicants must currently be authorized to work for any employer in the U.S.  We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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.

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For hires based in the United States, Vir Biotechnology, Inc., participates in E-Verify.

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