Senior Director, Global Pharmacovigilance Operations & Compliance

Vera Therapeutics, Inc.

United States

Remote

USD 270,000 - 370,000

Full time

47 hours ago
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Benefits offered by this job

Competitive base pay with bonus
Equity options
Full benefits
401k match
Flexible time off

Job summary

Vera Therapeutics, Inc. is seeking a Senior Director of Pharmacovigilance Operations & Compliance to lead global PV operations and ensure regulatory compliance across the portfolio.

This remote-ready role partners with the Head of DSPV to shape strategy, budget, and resourcing, while directing case management, vendor oversight, and inspection readiness. The candidate will drive safety systems, MedDRA updates, and PV process improvements, collaborating with QA, Regulatory, Medical Affairs,

Qualifications

  • Healthcare or life sciences degree required; advanced degree preferred.
  • 15+ years of pharmacovigilance experience, including 5+ years in a people-leadership role.
  • Experience with clinical and commercial lifecycle phases is required.
  • Demonstrated experience managing PV Operations through multiple Health Authority inspections (e.g., FDA, EMA, MHRA).
  • Experience spanning clinical-stage and commercial/post-marketing environments, ideally across multiple therapeutic areas.
  • Deep knowledge of pharmacovigilance regulations and guidelines.

Responsibilities

  • Own and drive global PV Operations strategy, including planning, implementation, and management, in the US and globally.
  • Represent DSPV Operations in senior leadership interactions and budget planning; own DSPV Operations budget.
  • Coordinate inspection readiness and lead PV during Health Authority inspections and audits.
  • Oversee PV vendor selection, oversight, invoicing, and budget needs for operations and compliance.
  • Develop and implement an inspection readiness program with PV stakeholders.
  • Lead training and set training requirements and compliance.

Skills

PV leadership
Global PV experience
Regulatory compliance

Education

Healthcare or life sciences degree
Advanced degree preferred

Tools

MedDRA

Job description

Vera Therapeutics, Inc. is seeking a Senior Director of Pharmacovigilance Operations & Compliance to lead global PV operations and ensure regulatory compliance across the portfolio.

This remote-ready role partners with the Head of DSPV to shape strategy, budget, and resourcing, while directing case management, vendor oversight, and inspection readiness. The candidate will drive safety systems, MedDRA updates, and PV process improvements, collaborating with QA, Regulatory, Medical Affairs,

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