Simplify Logo

Full-Time

Senior Director

Global Pharmacovigilance & Risk Management Head of Medical Safety

Confirmed live in the last 24 hours

Vir Biotechnology

Vir Biotechnology

501-1,000 employees

Develops treatments for infectious diseases

Data & Analytics

Compensation Overview

$225.5k - $329.5kAnnually

+ Bonus + Equity

Expert

Remote in USA

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Management
Marketing
Requirements
  • Medical degree (MD/DO), PharmD, or equivalent
  • 13+ years of related experience with 8+ years leading Safety Teams
  • Experience in authoring safety signal assessment reports, DSUR, PBRER, and RMP
  • Experience with Global regulations and ICH guidance governing pharmacovigilance and risk management
  • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding
  • Proven record as a people leader in a remote environment maximizing team cohesion, performance, and efficacy
Responsibilities
  • Develop talent and provide leadership to Global PVRM Medical Safety team
  • Provide strategic planning, implementation, and management of Global PVRM Medical Safety activities
  • Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations
  • Support inspection readiness and provide expertise in audits, inspections, and CAPAs
  • Responsible for development of Global PVRM Medical Safety related procedural documents
  • Represent Global PVRM Medical Safety as a leader on project teams and committees
  • Lead Safety Review Management Team to address any safety-related issues for Vir products
  • Contribute to safety related sections of clinical study documents
  • Perform medical review of Individual Case Safety Reports
  • Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information
  • Provide leadership in regulatory authority interactions regarding safety and risk management
  • Lead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities

Vir Biotechnology is at the forefront of combating infectious diseases, leveraging advanced technologies such as a proprietary monoclonal antibody platform along with machine learning and artificial intelligence. This focus not only prioritizes public health but also fosters a culture of continuous innovation and commitment to scientific excellence. Working here means contributing to pivotal developments that address some of the most pressing global health challenges today, such as influenza, HIV, and COVID-19, in an environment that values cutting-edge research and a collaborative spirit.

Company Stage

Grant

Total Funding

$908.6M

Headquarters

San Francisco, California

Founded

2016

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

-2%

2 year growth

20%

Benefits

Comprehensive healthcare coverage

Employer matched 401(k)

Employee stock purchase plan

Childcare assistance

Tuition reimbursement