Manager, Post-Marketing Pharmacovigilance

🕒 Setembro 7

❄️ Minnesota – Remoto

❄️ Minnesota – Remote

💵 $126.000 - $140.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🎯 Marketing

👻 Score fantasma 3%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Celcuity

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Celcuity é uma empresa de biotecnologia em estágio clínico desenvolvendo terapias direcionadas que bloqueiam a via PI3K/AKT/mTOR (PAM) para tratar múltiplos tumores sólidos. Seu principal candidato, gedatolisib, é um inibidor potencial inédito pan-PI3K e mTORC1/2, sendo avaliado em ensaios clínicos para câncer de mama e próstata. A empresa avança com um pipeline focado em fornecer tratamentos oncológicos transformadores e direcionados, conduzindo desenvolvimento clínico e pesquisa orientada por dados para apoiar a adoção regulatória e médica.

Descrição

• Support vendor management and oversight of end-to-end ICSR collection, processing, reconciliation and safety reporting activities of post-marketing cases performed by the safety vendor • Review safety vendor project plans to ensure processes and procedures are documented appropriately and maintained • Monitor safety vendor deliverables and action items to ensure compliance with timelines • Provide guidance and subject matter expertise to the safety vendor for PV operational activities • Ensure on-time submission of expedited and aggregate safety reports through effective vendor management and routine review of vendor performance metrics • Conduct routine retrospective quality control of safety cases processed by the safety vendor • Oversee reconciliation between safety database and Call Center and other post-marketing sources • Support the development and maintenance of internal PV policies, SOPs, and training programs • Contribute to the preparation and submission of safety reports including PSUR/PBRER and PADER • Act as safety liaison between the PV department and internal stakeholders • Perform other duties as assigned

🎯 Requisitos

• Bachelor’s degree in life science (RN, Pharmacist); or relevant experience • 4–6 years of direct pharmacovigilance experience, with a specific focus on post-marketing safety • Deep understanding of FDA guidelines • Experience with Argus, preferred • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels • Strong interpersonal skills for interacting with employees and leaders across various levels and functions • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint • Ability to work in a team or independently as required • Outstanding organizational skills with the ability to prioritize • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization • Flexible and willing to learn; adapting to business and site needs in a dynamic environment • Maintain a positive, approachable and professional attitude

🏖️ Benefícios

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays