- Taiho Oncology (Princeton, NJ)
- …ensure best practices. + Supports the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization ... Manager in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment... sciences. + Experience in signal detection, safety surveillance, risk mitigation and risk management … more
- CSL Behring (King Of Prussia, PA)
- …Reporting to the Head of Risk Management , Aggregate Reports & Pharmacovigilance , as the **Senior Manager , ICSR Quality** , you will have Individual Case ... operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL… more
- Parexel (Olympia, WA)
- …signal detection methodologies **Brand safety Physicians (as applicable)** + Contribute to Pharmacovigilance and Risk Management planning for designated ... highlighting and tracking potential issues + Support the preparation and maintenance of Risk Management Plans + Prepare and review periodic safety reports… more
- Sumitomo Pharma (Providence, RI)
- …a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to ... to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities**… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …requirements and internal standards. As a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders ... The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting...and consultant resources in audit conduct and reporting. + ** Risk -Based Audit Planning** : Support the development and maintenance… more
- BeOne Medicines (Emeryville, CA)
- …Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science ... + Update Reports (PSURs), Periodic Benefit- Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). + Lead and demonstrate ability to resource,… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …in clinical study team meetings for assigned compounds + Participate in other risk management activities as appropriate for assigned compounds + We may ... The Senior Manager of Global Patient Safety (GPS) will play...PhD, or PharmD + Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech… more
- CGI Technologies and Solutions, Inc. (Boston, MA)
- **IT Project Manager - Life Sciences** **Category:** Project Management **Main location:** United States, Massachusetts, Boston **Position ID:** J1225-1026 ... forums, issue resolution, and decision-making in line with established governance structures. Risk , Issue, Dependency & Vendor Management . Proactively identify,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and advisory meetings; and coordinate grant applications for scientific merit. + Develop risk management documents and ensure that all product failure modes and ... Become a **maker of possible** with us. **Medical Affairs Manager , Infusion Preparation & Delivery (IPD)** **Scope:** In this... risk mitigation measures are included. + Contribute when necessary… more
- Sanofi Group (Morristown, NJ)
- …+ Quality focused, able to develop good practices, using a critical data-driven and risk management approach + Ability to work autonomously and efficiently to ... for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities eg: leading or contributing to key study documents and… more
- Sanofi Group (Morristown, NJ)
- …agencies + Demonstrated capability to challenge decision and status quo with a risk - management approach + Ability to work within a matrix organization, within ... Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts:… more
- Sanofi Group (Cambridge, MA)
- …Scientific External Engagement, Procurement etc ), responsible for timelines, budgets and contingency/ risk management plans to assure successful execution of the ... medical/clinical input to study-related documents such as study plans eg Study risk management plan, Monitoring and centralized monitoring plans + Participate… more
- Sanofi Group (Morristown, NJ)
- …Scientific External Engagement, Procurement etc.), responsible for timelines, budgets and contingency/ risk management plans to assure successful execution of the ... communicate appropriately with all function stakeholders (eg clinical operations, project management , Patient Safety and Pharmacovigilance , regulatory, Finance,… more
- Parexel (Columbia, SC)
- …does not include any direct medical advice on patient care or management + Communicate with relevant sponsor counterparts on challenges and accomplishments related ... actions contributing to the success of the study/project and risk mitigation + Creating a sense of urgency on...Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support * Provide medical input into PV workflows… more
- BeOne Medicines (San Mateo, CA)
- …development intelligence, US Marketing, Global Marketing, US Sales, safety/ pharmacovigilance , molecular diagnostics, new markets, and translational research. The ... Values Essential Functions: + Oversee the daily 1st line manager activities of the Field Medical Team while providing...and report on FMD goals and objectives including performance management and employee development + Prepare, along with HQ… more