Senior Manager of Global Pharmacovigilance Operations

1 week ago


San Francisco, California, United States Vir Biotechnology, Inc. Full time

Job Overview:
Vir Biotechnology, Inc. is seeking a Senior Manager for Pharmacovigilance Operations on a contract basis to bolster the global Pharmacovigilance Operations team.

This position will report directly to the Director of PVRM Operations.

KEY RESPONSIBILITIES AND DEVELOPMENT OPPORTUNITIES:
Oversee the daily operations of the Pharmacovigilance Operations Department.

Ensure adherence to standard operating procedures (SOPs), regulatory safety, and pharmacovigilance in line with both US and international regulations.


Manage operational responsibilities associated with electronic Trial Master File documentation, including quality assessments, organization, upkeep, and storage in accordance with study protocols.

Assist with the Pharmacovigilance mailbox, ensuring all communications are processed, requests are identified, and that emails are prioritized and organized while following up on pending deliverables.

Conduct quality assessments of individual case safety reports (ICSRs).

Track submissions of ICSRs and aggregate safety reports (including line listings, DSURs, PADERs, PSURs/PBRERs, IND Annual Reports, etc.).

Engage with pharmacovigilance and clinical vendors regarding all pharmacovigilance operations activities.

Contribute to the initiation of new clinical trials, including the creation of study-specific Safety Management Plans and Forms.

Assist in the drafting and maintenance of Global PVRM and safety-related cross-functional SOPs and work instructions.

Oversee the review of Safety Regulatory Intelligence within Global PVRM.

Support additional activities and special projects as needed.

QUALIFICATIONS AND EXPERIENCE REQUIRED:


A degree in Nursing, Pharmacy, or a related field with a minimum of 5 years of experience in drug safety/pharmacovigilance operations, including extensive exposure to Trial Master File (TMF) and ICSR activities.

Proficient understanding of domestic and international adverse event reporting regulations (ICH, EMA GPV, GCP, FDA, etc.).

Experience in case management and processing activities.

Familiarity with ARGUS or other safety databases.

Knowledge of MedDRA/WHODrug for coding adverse events, medical history, and concomitant medications.

Experience in writing SOPs.


This is a hybrid role requiring a presence in the office on certain days each week.

The anticipated compensation for this role ranges from $55.00 to $78.00 per hour, with actual pay determined by experience, qualifications, geographic location, and other job-related factors.

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