- Sumitomo Pharma (Pierre, SD)
- …+ Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a ... Experience in oncology is highly desired + **Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and… more
- Lilly (Indianapolis, IN)
- …line management. Other Information/Additional Preferences: + Strong understanding of pharmacovigilance , drug safety, regulations and safety systems. + Proven ... experience managing global, cross-functional projects in a matrixed environment. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in project management tools and techniques. + Excellent oral and written communication… more
- US Tech Solutions (CA)
- …* Perform **quality review** of **external providers'** reconciliation tasks for clinical and post-marketing ( **medical information, product complaints, and ... This role will be 100 % remote. Candidates must posses **3 to 5 years of experience** or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a **structured… more
- Lilly (Indianapolis, IN)
- …and in support of the European Union Qualified Person for Pharmacovigilance (EU QPPV). **Benefit-Risk Management** **Leadership** **1) End-to-End Business Process ... internal expert to provide specialized knowledge within the area of Pharmacovigilance risk management and risk minimization activities. + Collaborate with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance ... proven abilities with team development, in depth understanding of pharmacovigilance operations, quality and compliance, planning, and assessing and implementing… more
- Sanofi Group (Morristown, NJ)
- …+ Minimum 10 years total experience in international global pharmacovigilance activities including experience in data systems implementation, post-marketing and/or ... clinical development pharmacovigilance . + Understanding.... + Understanding of the principles and goals of Pharmacovigilance . + Vendor management experience + Knowledge of Oracle… more
- Lilly (Indianapolis, IN)
- …and execution Serve to elevate the profile of GPS and the science of pharmacovigilance as an essential obligation of the company by establishing a visible presence ... responses. + Exercise broad external influence with regulators and the broader pharmacovigilance community by providing input on critiques of draft guidance and by… more
- United Therapeutics (Little Rock, AR)
- …You have a background in nursing or pharmacy and you're passionate about pharmacovigilance ! You are a team player who loves quality, compliance, finding solutions ... practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both… more
- Novo Nordisk (Plainsboro, NJ)
- …against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the PV Oversight for NNI ... Relationship Reports to head of North America Operations Quality Pharmacovigilance Oversight. Maintains positive rapport and working relationships within and… more
- Ascendis Pharma (Palo Alto, CA)
- …the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more