[Hiring] Senior Director, Pharmacovigilance Operations & Compliance @Vera Therapeutics, Inc.

Role Description

This position is responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance operations and compliance system to adhere to all global regulatory requirements and internal processes and procedures.

• Own and drive global PV Operations strategy, including planning, implementation, and management, in the US and globally.
• Serve as a key advisor to the Head of DSPV on operational risk, resource allocation, and DSPV budget planning.
• Represent DSPV Operations in interactions with senior leadership and support due diligence activities.
• Manage internal and external staff allocated to operational PV activities, creating a highly efficient team.
• Own talent strategy for PV Operations, including hiring, development, performance management, and succession planning.
• Provide expert guidance and leadership based on in-depth knowledge of development and post-marketing safety requirements.
• Build and implement pharmacovigilance systems that are fully compliant with applicable worldwide Health Authority PV regulations.
• Provide oversight of systems and MedDRA updates in collaboration with the relevant PV vendor.
• Contribute to the selection of PV vendors to support an outsourced PV business model.
• Develop and implement an inspection readiness program with the contribution of other PV and non-PV stakeholders.
• Serve as the PV Operations lead/host during Health Authority inspections and audits.
• Responsible for a compliant and quality execution of all operational activities related to case management.
• Establish a system for identifying, preventing, and correcting compliance deviation.
• Oversee the setup of new safety projects, including development of study-specific Safety Management Plans.
• Contribute to, draft, and implement department SOPs and work instructions related to the PV activities.
• Contribute to signal detection, benefit-risk profile assessment, and aggregate reporting activities.
• Effectively collaborate with key stakeholders at all levels in the organization.
• Represent PV Operations as a leader on project teams, cross-functional committees, and governance bodies.
• Elevate a quality mindset across DSPV.
• Lead training activities, including setting training requirements and training compliance.
• Build and oversee PV regulatory intelligence activities.

Qualifications

• Healthcare or life sciences degree required; advanced degree (e.g., PharmD, RN, MPH, or scientific PhD) preferred.
• 15+ years of pharmacovigilance experience, including 5+ years in a people-leadership role managing global PV teams.
• Experience with clinical and commercial lifecycle phases is required.
• Demonstrated experience managing PV Operations through multiple Health Authority inspections.
• Experience spanning both clinical-stage and commercial/post-marketing environments.
• Skilled in process gap assessments and process enhancements.
• Strategic thinker.
• Strong execution and drive for results skills.
• Comfortable working independently.
• Deep knowledge of pharmacovigilance regulations and guidelines.

Requirements

• Experience in pharmacovigilance operations.
• Ability to manage global teams effectively.
• Strong leadership and communication skills.
• Expertise in regulatory compliance and safety requirements.

Benefits

• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.
• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off and a number of paid holidays.