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Exelixis, Inc.
Alameda, CA, United States
Director, Drug Safety Operations page is loaded Director, Drug Safety Operations Apply locations Remote Alameda, CA King of Prussia, PA time type Full time posted on Posted 11 Days Ago job requisition id JR5451 SUMMARY/JOB PURPOSE: This role is responsible for overseeing all aspects of drug s
Job Source: Exelixis, Inc.Eli Lilly and Company
South San Francisco, CA, United States
Eli Lilly and Company seeks an Executive Director, Drug Safety Physician to ensure standard processes and procedures for all aspects of pharmacovigilance. Collaborate with safety systems associates, ensuring Argus support of safety reporting, audits and inspections, aggregate reports, and signal detection. Oversee SOPs development and management pl
Job Source: Eli Lilly and CompanyEli Lilly and Company
South San Francisco
Eli Lilly and Company seeks an Executive Director, Drug Safety Physician to ensure standard processes and procedures for all aspects of pharmacovigilance. Collaborate with safety systems associates, ensuring Argus support of safety reporting, audits and inspections, aggregate reports, and signal det...
Job Source: Eli Lilly and CompanyRecor Medical Inc.
Palo Alto, CA, United States
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join
Job Source: Recor Medical Inc.Exelixis
Alameda, CA, United States
SUMMARY/JOB PURPOSE: The Senior Staff Engineer, Product Management - Business Applications will ensure high-quality Drug Development Business Applications support. The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective. Implements right-fit product and execut
Job Source: ExelixisMirum Pharmaceuticals
Foster City, CA, United States
POSITION SUMMARY The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The optimal candidate participate will lead the department and also collaboratively work across
Job Source: Mirum PharmaceuticalsGRAIL
Menlo Park
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a mul
Job Source: GRAILGRAIL
Menlo Park, CA, United States
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and s
Job Source: GRAILSan Carlos, CA, United States
(Sr.) Medical Director, Drug Safety
Remote Based
Oncology-Hematology | Cell Therapy
Pay Range: $280,000 - $340,000
Overview:
Meet are exclusively partnering with a mid-sized biotech who have developed a T-cell based immunotherapy platform targeting both solid and liquid tumors. Off the back of their first FDA approval they are anticipating significant growth of 30% across multiple business sectors in H2 of this year.
Reporting to the VP, Drug Safety you will Provides medical expertise within the Drug Safety department throughout the lifecycle of products in development and post marketing. Contributes to the analysis, review, and approval of Individual Case Safety Reports (ICSRs) and contributes to and provides the medical review for aggregate safety reports, including but not limited to analyses of adverse events, Periodic Reports or marketed and investigational products. Supports the ongoing evaluation of safety information for products in development and on the market for signal detection purposes and to provide proactive risk management strategies.
Responsibilities: Reviews all appropriate safety data from various sources throughout the product development life cycle to proactively identify any new safety issues that may require further evaluation to determine a causal relationship with products in development or on the market.
Conducts medical review and assessment of clinical trial and post marketing cases for all products, ensuring the case narratives are medically accurate, the events within cases are properly coded and have the proper labeling assessment, and that cases are queried for additional information as needed.
Authors or provides medical review of all aggregate safety reports such as Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
Authors or contributes to safety sections of regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and responses to regulatory authorities
Participates in investigators' meetings to provide training on adverse events reporting as required.
Education and Background: Medical degree
Knowledge of pre- and post-marketing US and Global regulations
Familiar with Medical Coding
To learn more about the position please contact [email protected] , or contact 628-229-9023
Email Alert for Medical Director, Drug Safety jobs in San Carlos, CA, United States
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