Deciphera Pharmaceuticals
201 - 500 funcionários
Fundada em 2016
🧬 Biotecnologia
💊 Farmacêutico
Biotechnology • Pharmaceuticals
A Deciphera Pharmaceuticals é uma empresa de biotecnologia dedicada a combater o câncer, desenvolvendo inibidores de quinase inovadores para melhorar os resultados dos pacientes. A empresa se concentra em projetar inibidores de quinase de controle de chave para abordar os mecanismos de resistência tumoral e farmacológica, com o objetivo de aprimorar as respostas ao tratamento para pacientes com câncer. A Deciphera possui um portfólio diversificado de candidatos a medicamentos, incluindo ripretinibe e vimseltinibe, e está comprometida em causar um impacto significativo na vida dos pacientes com câncer. A partir de junho de 2024, a Deciphera é uma subsidiária integral da ONO Pharma e continua a trabalhar para melhorar a saúde humana por meio de suas inovações científicas e abordagem centrada no paciente.
Associate Director, Pharmacovigilance Scientist
🕒 Abril 7
🍂 Massachusetts – Remoto
💵 $162.000 - $223.000 / ano
⏰ Tempo Integral
🟠 Sênior
👔 Diretor
🦅 Patrocina Visto H1B
🗣️🇺🇸🇬🇧 Inglês obrigatório
📊 Verifique sua pontuação de currículo para esta vaga
Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.
Deciphera Pharmaceuticals
201 - 500 funcionários
Fundada em 2016
🧬 Biotecnologia
💊 Farmacêutico
Biotechnology • Pharmaceuticals
A Deciphera Pharmaceuticals é uma empresa de biotecnologia dedicada a combater o câncer, desenvolvendo inibidores de quinase inovadores para melhorar os resultados dos pacientes. A empresa se concentra em projetar inibidores de quinase de controle de chave para abordar os mecanismos de resistência tumoral e farmacológica, com o objetivo de aprimorar as respostas ao tratamento para pacientes com câncer. A Deciphera possui um portfólio diversificado de candidatos a medicamentos, incluindo ripretinibe e vimseltinibe, e está comprometida em causar um impacto significativo na vida dos pacientes com câncer. A partir de junho de 2024, a Deciphera é uma subsidiária integral da ONO Pharma e continua a trabalhar para melhorar a saúde humana por meio de suas inovações científicas e abordagem centrada no paciente.
Descrição
• 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.
🎯 Requisitos
• 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.
🏖️ Benefícios
• 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.
Candidatar-se
