Vice President, Pharmacovigilance

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

📋 Description

• Create and implement a global pharmacovigilance strategy that aligns with corporate goals, regulatory standards, and the company’s dedication to patient safety.

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

• Act as a senior safety advisor to the executive leadership team.

• Represent Pharmacovigilance in governance committees, leadership forums, and discussions with health authorities.

• Ensure that global pharmacovigilance operations are compliant, inspection-ready, scientifically sound, and in accordance with regulatory standards, GCP guidelines, and internal quality systems.

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

• Build, nurture, and lead a high-achieving pharmacovigilance organization.

• Cultivate a culture centered on scientific excellence, accountability, collaboration, and patient-oriented decision-making.

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

⛳️ Requirements

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

• 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.

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

• Experience in safety governance, benefit-risk assessment, signal detection, risk management, safety reporting, and ensuring inspection readiness.

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

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

• Oncology experience is highly preferred.

• Experience in supporting small molecule therapeutics.

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

• Familiarity with a global, outsourced operating model that utilizes CROs and external pharmacovigilance vendors.

• Proven success in building, scaling, and evolving pharmacovigilance organizations, systems, and operating frameworks.

• Experience in supporting regulatory submissions, product launches, and post-marketing safety initiatives across multiple global markets.

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

🏝️ Benefits

• Equity-based compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company match.

• Life insurance.

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

• Annual performance bonus.

• Long-term incentive plan.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional development.