Vera Therapeutics, Inc. is a clinical-stage biotechnology company developing treatments for immunological kidney diseases. Its lead program, atacicept, is in Phase 2b and Phase 3 trials for IgA nephropathy (IgAN), alongside research into lupus nephritis and other immunologic conditions. The company’s work brings together clinical development, scientific research, and patient engagement, with a focus on improving care for people living with these diseases.
Senior Director of Pharmacovigilance Operations and Compliance
Lead global pharmacovigilance operations and compliance at Vera Therapeutics, an autoimmune biotechnology company. Oversee safety systems, vendors, inspections, budgets, and PV teams.
Америка Құрама Штаттары270 000 $ – 370 000 $ / жыл
ҚашықтанТолық жұмыс күніАға маманҚажетті Тіл: ағылшын тіліСәйкестікСипаттама
- Build and lead the company’s pharmacovigilance operations, compliance infrastructure, and staff
- Set global PV Operations strategy and oversee its planning, implementation, and management
- Advise the Head of DSPV on operational risks, resource needs, and budget planning
- Manage the DSPV Operations budget, including CRO and vendor contract costs
- Represent DSPV Operations to senior leaders and external partners
- Lead internal and external teams, including hiring, development, performance management, and succession planning
- Develop and implement pharmacovigilance systems that meet global compliance requirements
- Oversee safety systems, MedDRA updates, PV vendors, quality measures, invoices, and budgets
- Create inspection-readiness programs and lead PV Operations during FDA, EMA, and MHRA inspections and audits
- Ensure compliant case management and timely submission of expedited safety reports
- Establish processes to identify, prevent, and correct compliance deviations and implement CAPAs
- Set up safety projects, Safety Management Plans, safety systems, and PV database configurations
- Write and implement PV standard operating procedures and work instructions
- Contribute to signal detection, benefit-risk assessments, and aggregate reporting
- Coordinate with Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing
- Represent PV Operations on project teams, committees, and governance groups
- Lead training programs and oversee training compliance
- Develop and oversee pharmacovigilance regulatory intelligence activities
Талаптар
- A degree in healthcare or life sciences
- More than 15 years of pharmacovigilance experience
- At least five years leading people and managing global PV teams
- Experience across clinical and commercial lifecycle stages
- Experience leading PV Operations through multiple health authority inspections, including FDA, EMA, and MHRA
- Experience in clinical-stage and commercial or post-marketing settings
- Experience in multiple therapeutic areas is preferred
- Skill in assessing process gaps and improving processes
- In-depth knowledge of pharmacovigilance regulations and guidelines
Артықшылықтар
- Annual performance incentive bonus
- Equity for new hires
- Ongoing performance-based equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Flexible time off
- Paid holidays