- Taiho Oncology (Pleasanton, CA)
- …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
- Bristol Myers Squibb (Madison, NJ)
- … management . + Strong knowledge of processes and global regulations for pharmacovigilance and benefit- risk management . + Demonstrated success in ... adaptable/flexible and managing multiple demands and shifting priorities. + Effective time management and comfortable handling risk and uncertainty. + Ability to… 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
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** We are looking for an experienced Associate Director, Program Manager to join our team. This successful candidate will provide program ... management expertise as an individual contributor to teams leading...drugs or devices which improve human health. The program manager may also be assigned to projects that contribute… 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 (Cambridge, MA)
- …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
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