Head of Drug Safety and Risk Management – Biotech Firm – San Diego, CA

Position Overview

Location: San Diego, CA. We are seeking a Head of Drug Safety and Risk Management to guide a cutting-edge biotechnology firm. In this role, you will lead global safety strategy, oversee risk management operations, and ensure regulatory compliance across clinical and commercial programs. If you thrive in an innovative, fast-paced environment and excel at building robust pharmacovigilance frameworks, this opportunity will allow you to drive meaningful impact in the biotech landscape.

Key Responsibilities

• Develop and execute a comprehensive drug safety and pharmacovigilance strategy aligned with the company’s clinical and commercial objectives.
• Oversee safety surveillance, adverse event review, signal detection, and risk assessment for clinical and marketed products.
• Implement and monitor global Risk Management Plans (RMPs), REMS, and other safety-related submissions to ensure effective risk mitigation.
• Ensure full compliance with FDA, EMA, and international pharmacovigilance regulations through timely safety reporting and submission management.
• Collaborate with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and Commercial teams to integrate safety strategies.
• Optimize drug safety systems, processes, and standard operating procedures to enhance efficiency and quality control.
• Build, mentor, and lead a high-performing team of pharmacovigilance and risk management professionals.
• Provide executive-level reporting on safety trends, emerging risks, and strategic recommendations to senior leadership and the board.

Required Qualifications

• Extensive experience in pharmacovigilance, drug safety, or risk management within the biotech or pharmaceutical industries.
• Proven track record managing global safety programs and ensuring regulatory compliance with FDA, EMA, and ICH guidelines.
• Strong background in medical, pharmacy, or life sciences disciplines.
• Demonstrated leadership in building and mentoring cross‐functional teams in a dynamic, high-growth environment.
• Exceptional communication and stakeholder management skills with the ability to influence at executive levels.
• Unwavering commitment to regulatory compliance, ethical practices, and patient safety.

Benefits & Perks

• Compensation: Competitive base salary ranging from $220,000 to $350,000, complemented by performance-based bonuses, equity, and long-term incentive plans.
• Benefits: Comprehensive executive benefits package including health, dental, and vision insurance, 401(k) with company match, and executive retirement plans.
• Additional perks such as signing bonuses, relocation assistance, professional development budgets, travel allowances, and flexible working arrangements may also be offered.