Vice President, Pharmacovigilance

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Formulate and implement the global pharmacovigilance strategy in line with corporate goals, regulatory standards, and patient safety priorities.

• Offer executive leadership in benefit-risk assessment, safety governance, safety monitoring, signal management, and risk management across both investigational and marketed products.

• Act as a senior safety consultant to executive leadership.

• Represent the Pharmacovigilance function in governance committees, leadership discussions, and engagements with health authorities.

• Ensure that global pharmacovigilance operations are compliant, ready for inspections, scientifically sound, and in accordance with regulatory demands, GCP standards, and internal quality systems.

• Develop and refine scalable pharmacovigilance frameworks, processes, quality systems, vendor collaborations, and operational capabilities.

• Build, nurture, and lead a high-performing pharmacovigilance team.

• Promote scientific excellence, accountability, collaboration, and patient-centric decision-making.

• Collaborate across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Technical Operations, and other essential functions.

⛳️ Requirements

• MD, DO, PharmD, PhD, or an equivalent advanced degree in science or healthcare.

• Over 15 years of progressive experience in pharmacovigilance, clinical safety, drug safety, or drug development within the biotechnology or pharmaceutical sectors.

• More than 8 years of leadership experience overseeing global pharmacovigilance, clinical safety, or patient safety teams.

• Proven experience in supporting products throughout clinical development and commercialization phases.

• Extensive knowledge of global pharmacovigilance regulations, guidelines, and industry best practices, including FDA, EMA, ICH, GCP, and other relevant requirements.

• Proficiency in safety governance, benefit-risk evaluation, signal detection, risk management, safety reporting, and readiness for inspections.

• A history of successful interactions with health authorities, regulatory inspections, audits, and cross-functional safety leadership.

• Exceptional strategic leadership, communication, decision-making, and stakeholder management abilities.

• Oncology experience is strongly preferred.

• Experience in supporting small molecule therapeutics.

• Previous experience leading pharmacovigilance operations for commercial-stage products.

• Experience in a global, outsourced operating model involving CROs and external pharmacovigilance providers.

• Proven success in building, scaling, and enhancing pharmacovigilance organizations, systems, and operational frameworks.

• Experience in supporting regulatory filings, product launches, and post-marketing safety initiatives in various global markets.

• Strong business acumen with the ability to align safety strategies with corporate objectives.

🏝️ Benefits

• Equity-based compensation.

• Medical, dental, and vision insurance.

• 401(k) retirement plan with company matching.

• Life insurance coverage.

• Flexible spending account for healthcare and/or dependent care expenses.

• Annual performance bonus.

• Long-term incentive program.

• Generous parental leave and family planning benefits.

• Opportunities for personal and professional development.