- Merck & Co. (North Wales, PA)
- Job DescriptionHighly advanced understanding of safety and/or risk management to allow for overall accountability for the assigned cross-departmental process ... product accountabilities including the development and execution of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/TA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on ... Expert - Signal Evaluation: Assists manager in assessing new signals. Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to… more
- Merck & Co. (North Wales, PA)
- …for the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related ... safety teams for the strategic planning and scientific reasoning that facilitates safety and benefit- risk evaluationsPlan and execute on -aggregate safety … more
- Merck & Co. (North Wales, PA)
- …the positionServe as a statistical representative and core member in multiple Risk Management Safety TeamsLead, coordinate, and provide biostatistical support ... safety teams for the strategic planning and scientific reasoning that facilitates safety and benefit- risk evaluationsPlan and execute on aggregate safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …nurses) at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in ... of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to ... ensures coordination with other project deliverables Is responsible for Safety Input to all activities for Risk ...for Safety Input to all activities for Risk Based Monitoring across the development project Physical Requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of clinical sections of study-level documents (eg, protocol, amendments)- of safety data to mitigate risk to trial participants for the assigned ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, ... Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management.Develop a strong, positive strategic business partnership with the global R&D business functions of Daiichi Sankyo. As a trusted partner,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, ... Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a… more
- Novo Nordisk Inc. (Boulder, CO)
- …TRU Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to Associate Director, EHS at US headquarters ... valued vendors. Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on… more
- Merck & Co. (Rahway, NJ)
- …responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing ... and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages… more
- Aequor (Golden Valley, MN)
- …partner and technical expert. JOB RESPONSIBILITIES: Safely operates equipment, understands food safety requirements and ability to perform risk assessments Basic ... skills with peers and with customers Basic understanding of food safety and human safety Ability to work in hot/warm/cool conditions within the plant Ability… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions ... ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... for proactive resourcing planning, risk assessment strategies and will focus on talent development...guidance and quality standards related to product release and safety .NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy -… more
- Merck & Co. (Durham, NC)
- …Standard Operating Procedures and execute according to established safety standards.-Position Responsibilities:Demonstrates, at all times, safe work habits ... and maintains a safe work environment. Understands and complies with all safety and company policies and procedures.Safely unloads and loads bulk chemicals from… more
- Merck & Co. (Rahway, NJ)
- …person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our ... relationships within and across work groups of formulators, engineers, safety and quality representatives.Foster culture of collaboration, learning and… more
- Novo Nordisk Inc. (WA)
- …Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and ... trials, in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites,… 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 ... equipment used in production Identifies and addresses compliance, environmental, safety , and process deviations as appropriate while notifying appropriate personnel… more
- Merck & Co. (Durham, NC)
- …be compliant with current good manufacturing procedures(cGMP), safety and environmental-requirements/regulations/guidelines. Effective communication both written and ... bending, crawling, stooping is required.Required to wear personal protective equipment including safety glasses, safety shoes, earplugs, gloves, hard hats, … more
