Senior Director, Pharmacovigilance Operations – Compliance

Vera Therapeutics, Inc.

. Create, direct, and manage the company’s pharmacovigilance operations and compliance infrastructure and staff .

Posted 10/13/2026full-timeRemote • United StatesSenior💰 $270,000 - $370,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance operations, compliance infrastructure, and leadership within global teams. Proficient in managing regulatory inspections, budget planning, and developing compliant safety systems.

Highest-signal resume keywords

Pharmacovigilance Operations ManagementRegulatory Compliance ExpertiseLeadership in Global PV TeamsExperience with FDA, EMA, and MHRA InspectionsProcess Gap Assessments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceSafety Systems ManagementBudget PlanningSignal DetectionCase ManagementCAPA ImplementationSOP DevelopmentQuality Metrics OversightProcess EnhancementsClinical Lifecycle Management

Soft Skills

Talent StrategyPerformance ManagementCollaborationTraining LeadershipCommunication

Tools & Technologies

PV DatabasesMedDRASafety Management PlansInspection Readiness Programs

Industry Keywords

HealthcareLife SciencesTherapeutic AreasClinical-Stage EnvironmentsCommercial/Post-Marketing Environments

About the role

Key responsibilities & impact

Create, direct, and manage the company’s pharmacovigilance operations and compliance infrastructure and staff
Own and drive global PV Operations strategy, planning, implementation, and management
Advise the Head of DSPV on operational risk, resource allocation, and budget planning
Own the DSPV Operations budget, including CRO and vendor contract spend
Represent DSPV Operations to senior leadership and external partners
Manage internal and external staff and own talent strategy, hiring, development, performance management, and succession planning
Build and implement globally compliant pharmacovigilance systems
Oversee safety systems, MedDRA updates, PV vendors, quality metrics, invoicing, and budgets
Develop and implement inspection readiness programs and lead PV Operations during FDA, EMA, and MHRA inspections and audits
Oversee compliant case management and timely expedited safety report submissions
Establish systems for identifying, preventing, and correcting compliance deviations and implementing CAPAs
Set up safety projects, Safety Management Plans, safety systems, and PV database configurations
Draft and implement PV SOPs and work instructions
Contribute to signal detection, benefit-risk assessment, and aggregate reporting
Collaborate with Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing
Represent PV Operations on project teams, committees, and governance bodies
Lead training and training compliance activities
Build and oversee PV regulatory intelligence activities

Requirements

What you’ll need

Healthcare or life sciences degree required
15+ years of pharmacovigilance experience
5+ years in a people-leadership role managing global PV teams
Experience with clinical and commercial lifecycle phases
Demonstrated experience managing PV Operations through multiple Health Authority inspections, including FDA, EMA, and MHRA
Experience spanning clinical-stage and commercial/post-marketing environments
Experience across multiple therapeutic areas is ideally preferred
Skilled in process gap assessments and process enhancements
Deep knowledge of pharmacovigilance regulations and guidelines

Benefits

Comp & perks

Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical insurance
Dental insurance
Vision insurance
401(k) match
Flexible time off
Paid holidays