- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication and risk minimization plansPresents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams - ... Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product - Safety Communication: - Collaborates with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks ... areas centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual ... for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk management ... provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk...support related to risk management planning, risk management sciences, and risk management tools and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety ... assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relationship building with key stakeholders: Foster the enhancement of an integrated safety culture from Research to postmarketing/lifecycle management . Create a ... go to contact for PSLs and GPTs for less typical safety issues where monitoring and management pathways are poorly defined or undefined. Mentor junior CSPV… more
- Tris Pharma (Monmouth Junction, NJ)
- …for the development of ad hoc aggregate safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent ... and leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management strategies in pre… more
- Insmed Incorporated (Bridgewater, NJ)
- …safety aspects in the Medical Monitoring Meeting Collaboration in Safety Management TeamProvide medical/scientific review of statistical analysis. Collaborate ... analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … safety studies, and contribute to the development and review of safety documents including Risk Management PlansEfficiency of Process, SOP: Leads the ... of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries out… more
- Merck & Co. (South San Francisco, CA)
- … safety or other EHS related field.-Proficiency in project management , budgeting, communication and organizational skills.Experience working with Federal, State, ... Job DescriptionPosition Description: Specialist, Environmental, Health, and Safety (EHS) This position is part of our Company's Environmental, Health, and Safety … more
- UT Health Tyler (Tyler, TX)
- …focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance, Patient Safety , Risk Management , Medical Staff Services and Practice ... together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting the...iden tification and use of evidence- based practice and management among all entities in the system while differentiating… more
- Catalent (Philadelphia, PA)
- …initiation date.Release batch within scheduling database.Communicates SQDC countermeasures and safety issues to Quality Management .Ensures QADC metrics are ... Document Control manages the communication between the operations/production, project management , shipping and quality assurance groups to ascertain pertinent… more
- Eisai, Inc (Nutley, NJ)
- …Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as Tableau, ... Master's degree or foreign equivalent in Computer Science, Information Technology Management , or Business Administration or closely related field plus 2 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic ... and non project initiatives. The Senior Director, Global Head of CR2 Project Management & Operational Excellence is responsible for supporting the Global Head of… more
- BioAgilytix (Durham, NC)
- …the patients who need them.In this role, you are responsible for GxP-compliant management of incoming and outgoing biological samples. Our clients trust us to ... and you will ensure the samples are checked into our Laboratory Information Management System (LIMS), managed according to our procedures, and available to our… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and ... process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North...and Closure) for assigned sites and clinical trials Verifies safety reporting and the proper handling, monitoring and storage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end delivery of External data in Daiichi ... Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable for the end-to-end delivery of External data in ... Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the investigations ... management system. Working closely with the Quality Senior Manager,...investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring deviations and health… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... Control Procedures Compliance with current good manufacturing procedures (cGMP), safety and environmental requirements/regulations/guidelines Required to wear personal protective… more
