Senior Director, Risk Management, DSPV

POSITION SUMMARY

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for the company's Risk Management strategy and Benefit Risk Office. The role focuses on creating a best-practice framework for Risk Management, benefit-risk assessments, RMPs, additional Risk Minimization Measures, and REMS programs to optimize proactive patient safety and minimize risk.

REQUIRED SKILLS & RESPONSIBILITIES

Strategy & Management: Serve as Project Manager for the PV Risk Management System; provide strategic expertise on risk management, risk minimization, and structured benefit-risk assessment frameworks.

Documentation: Support the development/review of Risk Management Plans (RMPs), REMS, and benefit-risk documentation; ensure alignment with Good Pharmacovigilance Practices and global regulations.

Cross-functional Collaboration: Work with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats to ensure global alignment; collaborate with PV Physician/Scientist leads on safety governance and benefit-risk strategy.

Execution & Oversight: Develop risk intervention strategies (e.g., healthcare professional communications); track commitments and metrics; manage outsourced RMP-related activities.

Technical Safety Support: Aid in signal characterization, safety governance presentations (MSRB/MSRC), and provide input on regulatory submissions (BLA, SBLA, MAA).

Compliance: Support internal/external audits and inspections.

QUALIFICATIONS

Education/Experience: PhD, Pharmacist, PharmD, DO, or MD with 12+ years of experience. Includes a minimum of 5-10 years in pharmaceutical industry/drug development and 5-10 years in PV/safety or clinical development.

Expertise: Exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred.

Technical Skills: Working knowledge of PV functions (operations through medical safety science), safety databases, and regulatory intelligence.

Competencies: Strong scientific and analytical/judgment skills; experience with project management; attention to detail; strong communication skills and experience presenting at meetings.

Salary: $220,000 - $305,000 USD

TO APPLY

Please apply via the online application at: https://job-boards.greenhouse.io/veratherapeuticsinc/jobs/4140120009