- BeOne Medicines (Emeryville, CA)
- …regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic ... **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction...Experience Report (PAER), Periodic Safety. + Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs),… more
- Stony Brook University (Stony Brook, NY)
- …(PI) Coordinator. Working under the supervision of the Trauma Program Manager and Trauma Medical Director , the Adult Trauma PI Coordinator will be ensuring the ... may include the following but are not limited to:** * Assists the Trauma Medical Director and the Trauma Program Manager to evaluate the effectiveness of… more
- Sallie Mae (Sterling, VA)
- …and institutional investors. Responsibilities include maintaining and updating internal reports that track investor engagement, managing the investor relations ... in this position. **What You'll Do** + Analyze and aggregate data models of Sallie Mae. + Plan and...and external reporting/ presentations. + Work with the Senior Director to develop, plan and implement investor relations plan… more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... report for inclusion into clinical, filing, and post-market reports + Accountable for daily, weekly, and monthly review...on the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician… more
- ThermoFisher Scientific (Greenville, NC)
- …management and oversight of all contracted services. **Discover Impactful Work:** The Associate/ Medical Director provides medical oversight of clinical ... **Marketed Products Support:** + Manages signal detection activities, scientifically reviews aggregate reports , contributes to label updates, supports dossier… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Support writing, review, and submission of applicable device contribution in aggregate reports (PSUR/PBRER, PADER). + Collaborate with PS Therapeutic ... to join the **Patient Safety Strategic Operations** team as an **Associate Director , Patient Safety Medical Device Safety** responsible for supporting activities… more
- HCA Healthcare (Thousand Oaks, CA)
- …by 2028. In partnership with the Division Vice President of GME, the Division Director of Graduate Medical Education (DDGME) is responsible for the operations, ... staff in the Division. + Will audit and run reports as needed from the residency management tool to...colleagues. Do you want to work as a(an) Division Director of Graduate Medical Education where your… more
- ThermoFisher Scientific (Wilmington, NC)
- …safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports , or ICFs) + Provide medical safety support for the ... assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)...accurate + Lead the overall preparation of periodic safety reports (eg PSUR, DSUR); provide medical safety… more
- Amgen (Washington, DC)
- …lives of patients while transforming your career. **Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote** **What you will do** ... risk minimization measures + Prepare/review safety sections of periodic aggregate reports + Provide safety input to...all use our unique contributions to serve patients. The Medical Safety professional we seek is a leader with… more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. **Global Safety Medical Director - Hematology/Oncology** **What you will do** Let's do this. ... risk minimization measures + Prepare/review safety sections of periodic aggregate reports + Provide safety input to...**Basic Qualifications:** MD or DO degree from an accredited medical school AND Completion of an accredited medical… more
- Lilly (Indianapolis, IN)
- …Case Management Medical Review Scientist is responsible for conducting comprehensive medical review of Individual Case Safety Reports (ICSRs), ensuring the ... for marketed products. Leadership for GPS + Develop cross-functional foundations (eg, aggregate review and signal detection, Safety Topic Reports , regulatory… more
- Ascendis Pharma (Princeton, NJ)
- …+ Ensure data integrity for safety data outputs from the Safety Database for aggregate reports , Health Authority requests or other safety requirements. + Liaise ... developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,...employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and authorship of ... critical documents (eg, protocols and amendments, ICFs, IBs, IMPDs, clinical research reports , Health Hazard Evaluations, Signal Evaluation Reports , INDs, NDAs,… more
- Astellas Pharma (Northbrook, IL)
- …countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping ... our focus on addressing unmet medical needs and conducting our business with ethics and...essential clinical documents (eg, Investigator Brochure, Protocols, Clinical Study Reports ), and global health authority interactions. + Participate in… more
- Taiho Oncology (Princeton, NJ)
- …in addition to resources on pharmacovigilance-related matters. Performance Objectives: + Lead aggregate reports (eg DSUR, PBRER, topic reports ) for ... on your experience in our rapidly evolving organization. Position Summary: The Associate Director , PV Sciences role will lead medical surveillance activities for… more
- CommonSpirit Health (Englewood, CO)
- **Job Summary and Responsibilities** The System Director , Planning Design & Construction (PDC) Planning and Design (PD) will be responsible for transforming, ... projects. This position will be accountable to lead the Medical & Facilities Planning & Design Platform (Architecture and...the business plan requirements of each project. The System Director PD will develop System specific staffing programs that… more
- AbbVie (Jersey City, NJ)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be… more
- Republic Services (Phoenix, AZ)
- **POSITION SUMMARY:** The Director , Financial Analysis & Planning (FAP) is responsible for the daily activities of the Financial Analysis and Planning department, ... tools for monthly and quarterly field reporting processes. The Director , Financial Analysis & Planning is also responsible for...developing goals and guidelines, updating field templates and designing reports to be used at all levels of the… more
- AbbVie (North Chicago, IL)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety … more
- Waystar (Lehi, UT)
- **ABOUT THIS POSITION** The Director of Trade Shows + Events will be responsible for the strategic planning and execution of all trade shows, user groups, and ... high-ROI events. They must be an excellent communicator who is able to aggregate information from multiple stakeholders to create a shared marketing vision in… more
