- Merck (Philadelphia, PA)
- …see if we are the right company for your long-term goals. The Clinical Safety and Risk Management (CSRM) Department in Rahway, NJ, Philadelphia, PA and ... in a team environment. Under the direction of the Clinical Safety and Risk Management Director, the intern(s) will learn about pharmacovigilance and … more
- Merck & Co. (North Wales, PA)
- …Scientist is a leader in drug safety and is responsible for overall clinical risk management and safety surveillance of assigned investigational ... of an Executive Director, Oncology, the Clinical Safety and Risk Management (CSRM)...3 years clinical experience* Experience in drug safety , pharmacovigilance and/or risk management *… more
- Merck & Co. (North Wales, PA)
- …expert in drug and/or vaccine safety and is responsible for the overall clinical risk management and safety surveillance of assigned investigational ... the way we approach serious diseases.Under the general direction of a Clinical Safety and Risk Management (CSRM) Team Lead, the CSRM Physician is an… more
- Merck & Co. (North Wales, PA)
- …Scientist is a leader in drug safety and is responsible for overall clinical risk management and safety surveillance of assigned investigational ... and marketed drugs.Primary Responsibilities *Support product development activities via Risk Management and Safety Teams...aspects of safety data evaluation, including assessing safety from multiple sources, eg clinical trials,… more
- Peacehealth (Washington, DC)
- …needs assessment for each team member. -Participates in patient safety stops. Provides clinical risk management guidance in safety stops including ... activities. -Consults with caregivers on issues related to risk management , patient safety , and...-Juris Doctorate preferred. EXPERIENCE/TRAINING: -Minimum of seven years of clinical risk management experience required.… more
- Sanaria Inc. (Rockville, MD)
- …to address any database system monitoring issues. Contribute to the development of Risk Management Plans. Conduct risk assessment relating to database ... the completeness, accuracy and consistency of data and data management processes to ensure that clinical data...Assist in the creation and review of progress and safety reports as needed to ensure the accuracy, scientific… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …strategy at the project team/governance level. You will be responsible for the continued safety assessment, evaluation and risk management of AZ products or ... Duties and Responsibilities: You will be responsible for the Clinical Safety strategy for assigned drug projects...communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …strategy at the project team/governance level. You will be responsible for the continued safety assessment, evaluation and risk management of AZ products or ... Duties and Responsibilities: You will be responsible for the Clinical Safety strategy for assigned drug projects...communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …strategy at the project team/governance level. You will be responsible for the continued safety assessment, evaluation and risk management of AZ products or ... Duties and Responsibilities: You will be responsible for the Clinical Safety strategy for assigned drug projects...communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …The role will collaborate very closely with customer teams, relevant leaders within Patient Safety Sciences & Risk Management Center of Excellence and wider ... safety project team activities. *Experience in safety signal management and/or the exploitation of clinical study safety data to define the safety … more
- Merck & Co. (North Wales, PA)
- … in partnership with Product Development, our Manufacturing Division and the Clinical Safety and Risk Management (CSRM) Risk Management ... drug-device combinations and vaccine-device combinations. Highly advanced understanding of safety / risk management to demonstrate primary responsibility… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …*Key Interactions: early TA Directors GPT/CPT members, BPO, Quality, training and Risk management , Early Statistical Biometrics and Innovation, Process and ... Sarah Cannon (Oncology and I/O), OFR. *Secondary interaction: Directors early study management , Study Teams, *Ensure clinical trial data provided for exploratory… more
- Kelly Scientific Resources (Englewood, CO)
- …in the development of CERs when necessary. Contributes toward post-market clinical safety and risk management programs as requested. Provides product ... Technical Writer ( Clinical /Medical Report Writer), Englewood, CO Pay Rate: $50-90K...clinical evaluation assessment and report development Basic project/timeline management skills and organizational skills Ability to prioritize and… more
- CHRISTUS Health (Alexandria, VA)
- …patient problems, expected outcomes and interpretation of diagnostic related clinical findings requiring intervention. Addresses medical/psychosocial, management ... functional Standard V. Safe Practice/Quality Care Regulations Incorporates patient safety practices/guidelines to promote a safe environment resulting in positive… more
- Seattle Genetics, Inc. (Bothell, WA)
- …* Minimum of 3 years (Director) experience in Drug Safety , Clinical Safety , Pharmacovigilance or Risk Management * Oncology safety science ... years (Director) experience in Drug Safety , Clinical Safety , Pharmacovigilance or Risk Management * Oncology safety science experience preferred… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- … risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk ... stakeholders. You will lead the collaboration with GSP and Clinical representatives and authors the Reference Safety ...planning for more complex products, including preparation of the safety aspects of Global Risk Management… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …This role needs product development expertise and experience with product design history and risk management processes as well as with FDA 21 CFR requirements ... and the device quality system. *Interface with suppliers to address development, risk management , change control, quality or auditing activities. *Work… more
- LMI (Frederick, MD)
- …brochures, clinical study protocols, case report forms, informed consent forms, safety reports, and clinical study reports) and other documents (eg, CRO ... schedules, records, and reports Non- clinical study reports supporting IND submissions Clinical study reports and Integrated Summary of Safety / Integrated… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk ... risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk … more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …Phase) * Post-Marketing Surveillance * MAA/BLA submissions * Periodic Reports * Risk Management Plans (authoring/working 'from scratch') * Governance board ... Phase) * Post-Marketing Surveillance * MAA/BLA submissions * Periodic Reports * Risk Management Plans (authoring/working 'from scratch') * Governance board… more
