Senior Director, Pharmacovigilance Operations & Compliance at Vera Therapeutics

Job description

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNA TM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com . At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney. Position Summary: 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. The qualified candidate will have experience in and perform multiple activities related to overall safety operations strategy across the portfolio, including oversight of case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, departmental strategy and training. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders, including the hiring and development of Drug Safety and Pharmacovigilance (DSPV) personnel. As a member of the DSPV leadership team, this role partners closely with the Head of DSPV to shape PV Operations strategy, own budget and resourcing decisions, and represent DSPV Operations to senior leadership and external partners. Responsibilities: Own and drive global PV Operations strategy, including planning, implementation, and management, in the US and globally internationally, in close alignment with the Head of DSPV on portfolio-level risk, resourcing, and business priorities. Serve as a key advisor to the Head of DSPV on operational risk, resource allocation, and DSPV budget planning; own accountability for the DSPV Operations budget, including CRO and vendor contract spend. Represent DSPV Operations in interactions with senior leadership and, as needed, and support due diligence activities (e.g., licensing, partnerships, M&A). 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 both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice. Build and implement pharmacovigilance systems that are fully compliant with the 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. Provide vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics, invoicing and budgetary needs related to operations and compliance. 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 (e.g., FDA, EMA, MHRA), coordinating responses and remediation