Vice President, Pharmacovigilance

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $335k - $460k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Develop and execute the global pharmacovigilance strategy aligned with corporate objectives, regulatory requirements, and patient safety • Provide executive leadership for benefit-risk evaluation, safety governance, safety surveillance, signal management, and risk management across investigational and marketed products • Serve as a senior safety advisor to executive leadership • Represent Pharmacovigilance in governance committees, leadership forums, and interactions with health authorities • Ensure global pharmacovigilance activities are compliant, inspection-ready, scientifically rigorous, and aligned with regulatory requirements, GCP standards, and internal quality systems • Establish and evolve scalable pharmacovigilance systems, processes, quality frameworks, vendor partnerships, and operational capabilities • Build, develop, and lead a high-performing pharmacovigilance organization • Foster scientific excellence, accountability, collaboration, and patient-focused decision making • Partner across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Technical Operations, and other key functions

🎯 Requirements

• MD, DO, PharmD, PhD, or equivalent advanced scientific or healthcare degree • 15+ years of progressive experience in pharmacovigilance, clinical safety, drug safety, or drug development within the biotechnology or pharmaceutical industry • 8+ years of leadership experience managing global pharmacovigilance, clinical safety, or patient safety organizations • Demonstrated experience supporting products across clinical development and commercialization • Deep understanding of global pharmacovigilance regulations, guidelines, and industry best practices, including FDA, EMA, ICH, GCP, and other applicable requirements • Experience with safety governance, benefit-risk assessment, signal detection, risk management, safety reporting, and inspection readiness • Track record of successful health authority interactions, regulatory inspections, audits, and cross-functional safety leadership • Strong strategic leadership, communication, decision-making, and stakeholder management skills • Oncology experience strongly preferred • Experience supporting small molecule therapeutics • Prior experience leading pharmacovigilance activities for commercial-stage products • Experience working in a global, outsourced operating model utilizing CROs and external pharmacovigilance vendors • Demonstrated success building, scaling, and evolving pharmacovigilance organizations, systems, and operating models • Experience supporting regulatory submissions, product launches, and post-marketing safety activities in multiple global markets • Strong business acumen with the ability to align safety strategy with corporate objectives

🏖️ Benefits

• Equity-based compensation • Medical, dental, and vision insurance • 401(k) retirement plan with company match • Life insurance • Flexible spending account for health care and/or dependent care • Annual performance bonus • Long-term incentive plan • Generous parental leave and family planning benefits • Opportunities for personal and professional growth