- SRI International (Plymouth, MI)
- …+ Extensive knowledge of medical terminology, clinical lab assessments, and pharmacovigilance . + Experience with IRB processes and regulatory submission platforms ... (eg, ePortal). **Candidate Traits** + Highly detail-oriented with exceptional organizational skills. + Strong leadership abilities with experience mentoring junior staff. + Proactive problem solver with ability to work in a dynamic environment. + Strong… more
- Lilly (Indianapolis, IN)
- …Clinical, Project Management, IT, etc.). + 2+ Prior experience in Pharmacovigilance area + Prior experience implementing small and large systems/technology projects ... **Other Information/Additional Preferences:** + Prior systems ownership, systems implementation. + Demonstrated application of process automation and analytics cross-functionally. + Demonstrated strategic thinking skills and driving broad change. +… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Clinical Scientist. and other functional areas such as GCO, biostats, regulatory, pharmacovigilance . The Director will be a key contributor to INDs, NDAs, BLAs, ... and other global regulatory filings and publications. The Director will foster relationships with opinion leaders in assigned therapeutic area. The CTP is a member of the study team and CDT. The CTP is expected to advance scientific and clinical knowledge,… more
- Lilly (Indianapolis, IN)
- …+ Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. + Serve as an IT systems business quality ... assurance (BQA) representative for IT systems, as assigned. + Perform IT Business Quality as defined in Computer System Policies and Procedures. + Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the… more
- Organon & Co. (Plymouth Meeting, PA)
- …in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance , Regulatory Affairs, etc.) + At least three years of experience ... in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked on programs in one or more… more
- Astellas Pharma (Northbrook, IL)
- …sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements + Providing legal and strategic support for a ... broad range of transactions for Medical Affairs and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Medical Affairs, including investigator-sponsored research agreements and escalations… more
- Adecco US, Inc. (Cary, NC)
- …care experience, preferably in oncology or chemotherapy administration or pharmacovigilance reporting * Oncology Certification preferred (not required) * Strong ... computer skills (Word, Excel, Outlook, Microsoft Teams, EMR systems) * Excellent communication skills and the ability to work independently * Knowledge of oncology/hematology nursing care best practices **_Ready to make a difference in oncology care?_**… more
- System One (Alameda, CA)
- …QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ... ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. Education: +… more
- Merck (Montgomery County, PA)
- …liaison** with commercial, medical affairs, market access, legal/compliance, pharmacovigilance , and external partners to ensure integrated program deployment. ... + **Develop and maintain relationships** with specialty pharmacies, infusion centers, provider networks, patient advocacy groups, and third-party vendors. + Partner with legal and compliance **to review promotional and non-promotional materials** , financial… more
- Genentech (South San Francisco, CA)
- …(eg, confidentiality, intellectual property, data privacy, interactions with customers, pharmacovigilance ) and proactively manage risk in external collaborations and ... evidence generation, ensuring alignment with Roche standards, legal frameworks, and evolving global regulatory expectations. External Partnerships & Community Impact + Lead strategic partnerships and serve as a senior medical spokesperson to advance population… more