- Sumitomo Pharma (Augusta, ME)
- …+ 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
- 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
- AbbVie (Chicago, IL)
- …AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. ... We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us… 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
- Boehringer Ingelheim (Duluth, GA)
- …for shaping and executing the digital vision for the Global Pharmacovigilance (GPV) organization, aligning with Boehringer Ingelheim's broader digital strategy and ... Defines and drives the digital vision and innovation roadmap for Global Pharmacovigilance in alignment with corporate strategy and GPV priorities. + Accelerates… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Astrix Technology (Monmouth County, NJ)
- …across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to ... on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) +… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for managerial oversight ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… 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