Senior Manager, Medical Safety Operations
1 day ago
The Senior Manager in Medical Safety Operations will support pharmacovigilance (PV) agreement maintenance, compliance oversight, and vendor oversight activities with respect to the individual case safety report (ICSR) processes at Mirum. This role collaborates with cross-functional teams, vendors, and partners/distributors to ensure the effective management of safety data exchange commitments.
Key Responsibilities
Develop and maintain PV agreements with license partners, distributors, and relevant parties to document safety data exchange commitments. Oversee compliance with safety data exchange commitments and ensure that PV vendor management is compliant with documented procedures and regulatory requirements. This includes ICSR quality oversight and submission compliance oversight.
Lead and address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions management related to PV processes. Conduct quarterly ICSR forecasts to ensure resources allocated by the PV vendor and internal Medical Safety staff are sufficient. Support data migration and map ICSR processes for new products as needed. Support post-market programs and audits on an as-needed basis.
Requirements
Minimum of 6 years direct pharmaceutical industry experience supporting global clinical study and post-market safety processing and reporting. Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives, and regulations governing both clinical studies and post-approval safety. Bachelor's degree in life sciences, MD, PhD, PharmD, BSN/RN preferred. Safety database experience is required, and PV quality management experience is preferred. Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.
-
Systems Engineer: Operational Safety Specialist
2 weeks ago
Foster City, California, United States Zoox Full timeJob Title: Systems Engineer: Operational SafetyZoox is a pioneering company in the development of full-stack autonomous mobility solutions for cities. Our System Design and Mission Assurance (SDMA) team plays a crucial role in constructing the safety case and validating that our vehicles are safe enough to be deployed for autonomous driving.Job Summary:We...
-
Foster City, California, United States Gilead Sciences Full timeJob Title: Senior Manager, Global Medical AffairsJob Summary:Gilead Sciences is seeking a highly skilled Senior Manager, Global Medical Affairs to join our team. This role will be responsible for managing and overseeing projects related to global medical affairs, including late phase programs, clinical trials, and medical communications.Key...
-
Senior Compute Safety Engineer
24 hours ago
Foster City, California, United States Zoox Full timeJob SummaryZoox is seeking a highly skilled Senior Compute Safety Engineer to join our Advanced Hardware Engineering team. As a key member of our team, you will be responsible for ensuring the safety and reliability of our compute systems.Key ResponsibilitiesPerform Failure Mode Effects Analysis (FMEA) on compute systems to identify potential safety...
-
Systems Safety Engineer
3 weeks ago
Foster City, California, United States Zoox Full timeJob Title: Systems Safety EngineerZoox is a leading innovator in autonomous mobility solutions, and we're seeking a highly skilled Systems Safety Engineer to join our team.The Systems Safety Engineer will play a critical role in ensuring the safe deployment and operation of our autonomous vehicles. This includes identifying potential safety hazards,...
-
Foster City, California, United States BioSpace Full timeJob DetailsSenior Study Monitor, Nonclinical Safety and PathobiologyUnited States - California - Foster CityGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the...
-
Senior Manager, Customer Engagement Operations
1 month ago
Foster City, California, United States BioSpace, Inc. Full timeJob Title: Senior Manager, Customer Engagement Operations - Technology and SystemsWe are seeking a highly skilled Senior Manager, Customer Engagement Operations - Technology and Systems to join our team. As a key member of our Customer Engagement Operations team, you will be responsible for ensuring the effective daily management of technologies and systems...
-
Senior Technical Program Manager
2 days ago
Foster City, California, United States Tata Technologies Full timeJob Title: Senior Technical Program ManagerAt Tata Technologies, we are seeking a highly skilled Senior Technical Program Manager to join our team in Foster city, CA. As a key member of our organization, you will play a critical role in strengthening our team and contributing to the success of our company.Job Summary:We are looking for a seasoned Technical...
-
Senior Property Manager
1 month ago
Foster City, California, United States Ascend Full timeJob OverviewAt Ascend Talent Solutions, we are seeking a highly skilled and experienced Commercial Real Estate Leader to join our team as a Senior Property Manager. This is a key leadership role that requires a strong background in property management, finance, and customer service.Key ResponsibilitiesFinancial Management: Develop and manage annual property...
-
Senior Property Manager
3 weeks ago
Foster City, California, United States Ascend Full timeJob SummaryAscend Talent Solutions is seeking a highly skilled and experienced Senior Property Manager to join our team. As a key member of our property management team, you will be responsible for the overall management of our commercial real estate portfolio, ensuring the fiscal and operational success of our properties.Key ResponsibilitiesDevelop and...
-
Senior Manager, Business Strategy Lead
3 weeks ago
Foster City, California, United States Gilead Sciences Full timeJob Title: Senior Manager, Business StrategyJob Summary:Gilead Sciences is seeking a Senior Manager, Business Strategy to join our Clinical Trial Capabilities organization. This role will be responsible for driving strategic and operational process improvements and/or implementation of processes for Clinical Operations. The successful candidate will have a...
-
People Operations Manager
4 weeks ago
Foster City, California, United States Zoox Full timeAbout the RoleZoox is seeking a seasoned People Operations Manager to join our team. As a key member of our HR function, you will play a critical role in shaping the employee experience and driving business outcomes.Key ResponsibilitiesDevelop and implement strategic talent plans to support business growth and objectivesPartner with senior leaders to drive...
-
Senior Manager, Customer Engagement Operations
4 weeks ago
Foster City, California, United States BioSpace, Inc. Full timeJob DescriptionThe Senior Manager, Customer Engagement Operations - Technology and Systems will report to the Associate Director, Customer Engagement Operations. This role will ensure effective daily management of the technologies and systems used for delivering customer programs and engagement activity. A keen understanding of the compliance landscape is...
-
Senior Manager, Development Sourcing
3 weeks ago
Foster City, California, United States Gilead Sciences Full timeAbout the RoleGilead Sciences is seeking a highly skilled Senior Manager, Development Sourcing to join our Development Operations team. As a key member of our organization, you will be responsible for developing custom applications and solutions to drive operational efficiency for Vendor Outsourcing (VO) by creating tools that streamline and automate VO...
-
Foster City, California, United States BioSpace, Inc. Full timeJob DescriptionThe Senior Manager, Customer Engagement Operations - Technology and Systems will report to the Associate Director, Customer Engagement Operations. The role will ensure effective daily management of the technologies and systems used for delivering customer programs and engagement activity. A keen understanding of the compliance landscape will...
-
Senior Manager, Customer Engagement Operations
1 month ago
Foster City, California, United States BioSpace, Inc. Full timeJob DescriptionSenior Manager, Customer Engagement Operations - Technology and SystemsThis is a critical role within our organization, responsible for overseeing the daily tactical technology operations and associated systems to support our US Customer Engagements across various engagement types. The ideal candidate will have a keen understanding of the...
-
Senior Toxicologist
1 week ago
Foster City, California, United States Gilead Sciences Full timeJob Title: Senior ToxicologistGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We are seeking a highly skilled Senior Toxicologist to join our Nonclinical Safety team.Key Responsibilities:Develop and implement nonclinical safety strategies to...
-
Senior Training Manager
2 weeks ago
Foster City, California, United States ATR International Full timeJob Title: Senior Training ManagerATR International is seeking a highly skilled Senior Training Manager to lead the development and implementation of knowledge/skill-based training programs for commercial field sales teams.Key Responsibilities:Design and deliver training programs focused on therapeutic disease state and product knowledge to ensure commercial...
-
Senior Salon Manager
2 days ago
Foster City, California, United States Tricoci Salon | Spa Full timeAbout Tricoci Salon & SpaWe're a leading name in the beauty industry, offering an experiential space where our clients and team members can discover their best selves. Our mission is to inspire confidence within every client by catering to their unique needs and providing an experience that's anything but ordinary.Job SummaryWe're seeking a highly motivated...
-
Facilities Operations Manager
3 weeks ago
Foster City, California, United States Naderi Engineering, Inc. Full timeJob SummaryWe are seeking a highly skilled Facilities Operations Manager to join our team at Naderi Engineering, Inc. This role will be responsible for coordinating and supporting various facilities programs, including project management, machine health monitoring, and electrical reliability.Key ResponsibilitiesCoordinate project management activities and...
-
Foster City, California, United States Gilead Sciences Full timeJob SummaryGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. We are seeking a Senior Director, Commercial Analytical Operations — Biologics Quality Control to provide strategic leadership and oversee daily operations in our Commercial Biologics QC team.Key...