ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Moonlake
, MD, United States
The global safety scientist role is responsible for providing scientific expertise to safety surveillance and risk management activities for MoonLake products in clinical development. The role actively contributes to setting the strategic direction within drug safety and to the development of safety standards and processes. Key Accountabilities:
Job Source: MoonlakeAstraZeneca GmbH
, MD, United States
Job Title: Global Clinical Program Lead Physician Location: Office Based Role in Boston MA with Flexibility Make a more meaningful contribution. Impact patients’ lives every day. AZ’s vision is to grow and expand the indications and assets in late phase respiratory and or immunology therapy areas to become a major player in the field. This Glo
Job Source: AstraZeneca GmbH© 2009 - 2024 Dayforce HCM, Inc. All Rights Reserved.
Riderwood, MD, United States
Thursday, April 18, 2024 POSITION SUMMARY:Provides risk evaluation services to underwriters, the internal customers, and provides risk elimination/control consultation to policyholders and external customers to reduce the potential for work related injuries and control workers compensation costs.________________________________________DUTIES AND RE
Job Source: © 2009 - 2024 Dayforce HCM, Inc. All Rights Reserved.Digging & Rigging, Inc.
North Point Village, MD, United States
Job Summary Under direction of the Safety Director, provides guidance and support for all employee to ensure compliance with local, State, and Federal regulations regarding safety and health. Responds to and assists with critical incidents that involve employees. The Safety Manager enforces all Digging & Rigging policies and procedures as such. E
Job Source: Digging & Rigging, Inc.University of Maryland Medical System
Towson
Job Description Job Description Company Description When you come to the University of Maryland St. Joseph Medical Center, you’re coming to more than simply a beautiful 37-acre, 218-bed suburban Baltimore, Maryland campus. You’re embarking on a professional journey that encourages opportunities, values a team atmosphere, and makes convenience and
Job Source: University of Maryland Medical SystemLatitude Inc.
Cockeysville, MD, United States
We are looking for responsible individuals who will lead a culture of safety and sustainability that complies with local, state and federal guidelines, while providing efficient and effective facilities supervision and execution. Salary: $110,000 - 130,000/year Safety & Environmental Responsibilities: Ensures compliance with all environmental, heal
Job Source: Latitude Inc.Southland Industries
Laurel, MD, United States
Southland Industries Safety Manager Laurel , Maryland Apply Now The site Safety Manager assists the Division Safety Manager and leadership in enforcing and regulating all safety procedures to ensure that Southland Industries meets all safety requirements in the field and all facilities by managing and coordinating all division safety
Job Source: Southland IndustriesZūm Services, Inc.
, MD, United States
Zūm has reimagined student transportation, the nation's largest mass transit system. Our integrated end-to-end cloud-based platform provides a modern service for school districts purpose-built around the needs of kids and the expectations of their families. Zūm provides one seamless, real-time interface for parents, drivers, schools, districts, adm
Job Source: Zūm Services, Inc., MD, United States
Description
Global Safety Physician
New Providence, NJ/Hybrid/Remote
Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has been approved in the United States and is awaiting approval in the European Union. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We are a team of over 300 patient-focused, purpose-driven employees who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn .
Position Overview
The Global Safety Physician will serve as the safety expert for assigned products. The Global Safety Physician is responsible for signal detection and evaluation, aggregate safety reviews, periodic aggregate safety report preparation, and the oversight of vendors for Individual Case Safety Reports (ICSRs).
The Global Safety Physician will support the continued development of the Drug Safety and Pharmacovigilance (DSPV) organization.
This position can be remote based in the US. There is a preference to be based on the East Coast with the ability to travel to the New Providence, NJ office as needed for business meetings. This role reports into the VP, Drug Safety.
Job responsibilities
Responsible for all safety data throughout the life-cycle for assigned product(s)
Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis.
Will develop the strategy and implementation of safety and benefit-risk management for assigned products.
Responsible for content in the aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products.
Perform medical oversight to the vendor on ICSRs, literature review, signal evaluation and aggregate report to ensure accuracy and completeness of the safety content.
Review and contribute to safety sections within clinical documents such as Investigator’s Brochure, Study Protocol, and Informed Consent Forms.
Support cross-functional safety management team meetings and collaborate with team members to ensure patient safety for assigned products.
Support and collaborate with cross-functional teams on safety related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries.
Provide support for the Safety Scientist on assigned work, such as vendor oversight.
Collaborate effectively with key stakeholders, including business partners and vendors, and ensure they are informed of evolving safety issues and strategies.
Support and contribute to the development of Pharmacovigilance Agreements as needed.
Requirements
Requirements
MD, required.
5 years+ of relevant experience in drug safety, depending on qualification, within the biotechnology or pharmaceutical industry is required. Oncology experience is preferred.
In-depth knowledge of pharmacovigilance regulatory requirements, ICH guidance, and other relevant regulatory guidance.
Knowledge of drug development process, safety monitoring and risk/benefit analysis in clinical trials.
In-depth knowledgeable of individual case medical review, signal detection and evaluation, aggregate data review and report, as well as safety labeling.
Experience with the writing/reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels.
Ability to work independently, and collaborate effectively with key stakeholders, including business partners and vendors. Good team player with the ability to be flexible.
Proficient with Microsoft Office.
Strategic thinking, strong writing and analytic skills, excellent verbal, written communication skills.
#J-18808-Ljbffr
Global Safety Physician jobs in , MD, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.