Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
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.
Associate Director, Pharmacovigilance Scientist
🕒 April 7
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Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
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
• Serves as lead PV Scientist for assigned product(s) – 60%. • Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation. • Leads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs). • Leads and manages the planning, preparation, writing, and review of risk management plans. • Performs literature surveillance. • Prepares materials for safety governance meetings. • Contributes to safety-related regulatory queries, including data coordination and analysis. • Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable). • Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications). • Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspection. • Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.). • Conducts impact assessments (e.g., updates to regulations, etc.). • Leads process improvement initiatives and consistency of cross-product processes. • Conducts functional trainings and shares knowledge with the team. • Supports deliverables for other products, where needed. • Manages, mentors, and trains junior members of the team. • Supports individual development of direct reports.
🎯 Requirements
• Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar role. • Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS). • Demonstrated experience in analysis and interpretation of medical and scientific data, including experience leading signal management activities and the preparation and authoring of aggregate reports in both post-marketing and clinical trials. • Excellent oral and written communication skills, including the ability to effectively communicate key considerations and decision points. • Detail-oriented with ability to think critically, prioritize tasks, and function independently. • Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations. • Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs. • Prior experience serving as an SME in audits and/or inspections.
🏖️ Benefits
• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.
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