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Role Description

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for our Risk Management strategy and Benefit Risk Office at Vera which strives for excellence and the creation of a best practice framework. As a Risk Management Lead, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and other Benefit Risk deliverables.

• Optimize the proactive impact made by the PV department at Vera while maximizing patient safety and minimizing/preventing patient risk.
• Serve as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track Vera’s PV Risk Management obligations.
• Provide recommendations and guidance on risk management and risk minimization strategy to ensure product risk management strategies are consistent worldwide.
• Work closely with cross-functional teams to ensure alignment of Vera’s global position for the PV risk management processes.
• Support the development of risk management plans (RMPs) in modular format and ensure alignment with Good Pharmacovigilance Practices.
• Remain up to date on all Regulatory intelligence as it relates to risk management.
• Aide in the development and review of risk minimization documents.
• Provide subject matter expertise and contributions to qualitative and quantitative structured benefit risk assessments.
• Collaborate with PV Physician Leads, Clinical Leads, and others on benefit risk assessment strategy.
• Develop and provide recommendations for appropriate risk management interventions.
• Monitor and report risk management metrics to ensure compliance.
• Provide centralized support, training, and leadership for safety and cross-functional members.
• Support inspections and audit activities regarding risk management processes.
• Work with PV Physician and PV Scientists to aid in the proper characterization and classification of Risk.
• Manage and oversee any outsourced RMP related activities to external vendors.

Qualifications

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience.
• Minimum 5-10 years in PV/safety OR clinical development preferred.
• Minimum 5-10 years of pharmaceutical industry/drug development experience.
• Strong track record of scientific and analytical thinking.
• Experience presenting at meetings is desirable.
• Good Critical thinking skills and ability to use analytical/judgment skills.
• Project Management Skills with ability to manage multiple priorities simultaneously.
• Attention to detail, computer literacy, knowledge of safety databases.
• Good working knowledge of all the functions within PV.

Requirements

• Work with integrity and proactively in a fast-moving environment.

Benefits

• Vera Therapeutics is committed to fair and equitable compensation practices.
• The anticipated base pay range is $220,000 — $305,000 USD.

Company Description

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.