Senior Director, Pharmacovigilance Operations – Compliance

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $270k - $370k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• 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

• 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

• 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