Current jobs related to Global Pharmacovigilance Operations Contractor - San Francisco - Vir Biotechnology, Inc.
-
Senior Pharmacovigilance Specialist
1 week ago
San Francisco, California, United States Biogen Full timeAbout This RoleBiogen is seeking a Senior Pharmacovigilance Scientist to join our Safety team. As a key member, you will oversee safety operations, manage safety signals, and develop aggregate reports and risk management plans. You will be the go-to expert, responding to safety inquiries, conducting literature reviews, and ensuring compliance with global...
-
Senior Pharmacovigilance Specialist
1 month ago
San Francisco, California, United States Biogen Full timeAbout This RoleBiogen is seeking a highly skilled Senior Pharmacovigilance Scientist to join our Safety team. As a key member of our team, you will be responsible for managing Pharmacovigilance activities, overseeing safety operations of clinical trials, and driving the development of aggregate reports and risk management plans.Key ResponsibilitiesLead and...
-
Pharmacovigilance Specialist
2 weeks ago
San Clemente, California, United States Glaukos Corporation Full timeJob Title: Pharmacovigilance SpecialistThis role requires an individual who will be processing adverse event information for spontaneous, solicited, literature, and phase IV study cases.Key Responsibilities:Perform drug safety activities to ensure compliance with pharmaceutical and medical device regulations.Responsible for global pharmacovigilance review of...
-
Pharmacovigilance Specialist
1 month ago
San Clemente, California, United States Glaukos Corporation Full timeJob Title: Pharmacovigilance SpecialistGlaukos Corporation is seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safety of our medical devices and pharmaceuticals.Key Responsibilities:Process adverse event information for spontaneous, solicited,...
-
Senior Manager of Drug Safety
2 weeks ago
San Diego, California, United States Arrowhead Pharmaceuticals, Inc. Full timeJob Title: Senior Manager of Drug Safety & PharmacovigilanceArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking a highly skilled Senior Manager of Drug Safety & Pharmacovigilance to join our team.Job Summary:The Senior Manager of Drug Safety &...
-
Vice President of Safety and Pharmacovigilance
1 month ago
South San Francisco, California, United States Allogene Therapeutics Full timeAbout Allogene TherapeuticsAllogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Our mission is to deliver readily available cell therapy on-demand, more reliably, and at greater scale to more patients.Job SummaryWe...
-
San Diego, California, United States Arrowhead Pharmaceuticals, Inc. Full timeAbout Arrowhead Pharmaceuticals, Inc.Arrowhead Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines that address intractable diseases by silencing the genes that cause them. Leveraging a broad portfolio of RNA chemistries and efficient delivery modes, our therapies trigger the RNA interference...
-
Senior Manager of Drug Safety
2 weeks ago
San Diego, California, United States Arrowhead Pharmaceuticals, Inc. Full timeJob Title: Senior Manager of Drug Safety & PharmacovigilanceArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking a highly experienced Senior Manager of Drug Safety & Pharmacovigilance to join our Quality Assurance team.Job Summary:The Senior Manager of...
-
Senior Manager, Drug Safety
3 weeks ago
San Diego, California, United States Arrowhead Pharmaceuticals Full timeJob Title: Senior Manager, Drug Safety & PharmacovigilanceJob Summary:Arrowhead Pharmaceuticals is seeking a highly skilled and experienced Senior Manager, Drug Safety & Pharmacovigilance to join our team. The successful candidate will be responsible for overseeing the pharmacovigilance quality assurance team, developing and implementing a comprehensive...
-
Pharmacovigilance Specialist
2 weeks ago
San Clemente, California, United States Glaukos Corporation Full timeJob Title: Pharmacovigilance SpecialistGlaukos Corporation is seeking a highly skilled Pharmacovigilance Specialist to join our team.About the Role:This is a unique opportunity to work in a fast-paced environment and utilize your expertise in pharmacovigilance to ensure compliance with pharmaceutical and medical device regulations.Key...
-
San Diego, California, United States Arrowhead Pharmaceuticals Full timeJob SummaryArrowhead Pharmaceuticals, Inc. is seeking a Senior Manager, Drug Safety and Pharmacovigilance Quality Assurance to oversee the company's drug safety and pharmacovigilance quality assurance activities. This role will be responsible for ensuring compliance with regulatory requirements and maintaining a robust global compliance program.Key...
-
Pharmacovigilance Specialist
2 months ago
San Clemente, United States Glaukos Corporation Full timeJob DescriptionPharmacovigilance Specialist - Onsite/hybridHow you will make an impact: This role requires an individual who will be processing adverse event information for spontaneous, solicited, literature and phase IV study cases. Perform Drug safety activities to ensure compliance with Pharmaceutical and Medical device regulations. This position will...
-
Senior Manager of Drug Safety
3 weeks ago
San Diego, California, United States Arrowhead Pharmaceuticals, Inc. Full timeAbout the RoleArrowhead Pharmaceuticals, Inc. is seeking a highly skilled and experienced Senior Manager of Drug Safety & Pharmacovigilance to join our Quality Assurance team. As a key member of our organization, you will be responsible for overseeing the quality, compliance, and alliance management activities of our Drug Safety & Pharmacovigilance...
-
Pharmacovigilance Specialist
2 weeks ago
San Clemente, California, United States Glaukos Corporation Full timeJob DescriptionGlaukos Corporation is seeking a highly skilled Pharmacovigilance Specialist to join our team in San Clemente, California. As a key member of our Pharmacovigilance department, you will be responsible for reviewing and processing adverse event information for spontaneous, solicited, literature, and phase IV study cases.Key...
-
San Francisco, California, United States Daiichi Sankyo, Inc. Full time{"title": "Global Regulatory Labeling Expert", "description": "Job SummaryDaiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Labeling Expert to join our team. As a key member of our Global Regulatory Team, you will be responsible for providing strategic and operational leadership on product labeling, ensuring compliance with all applicable...
-
File Operations Specialist
1 month ago
San Francisco, California, United States Advantech Global Full timeJob SummaryWe are seeking a highly organized and detail-oriented File Clerk to support the operations of a local Field Office for the U.S. Citizenship and Immigration Services (USCIS). As a File Clerk, you will play a critical role in facilitating the processing of forms and applications used in the adjudication process.Key ResponsibilitiesPerform file...
-
Senior Manager Safety Operations
2 weeks ago
San Diego, California, United States Arrowhead Pharmaceuticals, Inc. Full timeAbout the RoleArrowhead Pharmaceuticals, Inc. is seeking a highly skilled Safety Operations Manager to join our team. As a key member of our Safety Operations department, you will play a critical role in ensuring the safe and effective development of our innovative therapies.Key ResponsibilitiesLead the set-up of new clinical development programs,...
-
Medical Director, Global Safety Lead
2 weeks ago
South San Francisco, California, United States Biogen Full timeJob SummaryWe are seeking a highly skilled Medical Director, Global Safety to join our team at Biogen. As a key member of our safety team, you will be responsible for overseeing the medical safety aspects of our products, ensuring compliance with regulatory requirements, and providing strategic leadership within our clinical development programs.Key...
-
Clinical Study Start-Up Manager
2 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob SummaryWe are seeking a highly skilled Clinical Study Start-Up Manager to join our Pharmacovigilance team at Daiichi Sankyo, Inc. This role will be responsible for driving global Clinical Study Start-Up activities for PV Safety Operations.Key ResponsibilitiesRepresent PV Operations at multidisciplinary study meetings, providing guidance on safety...
-
Quality Director/Director, Clinical Operations
4 weeks ago
San Francisco, United States Larimar Therapeutics Full timeJob Title: Associate Director/Director, QualityLarimar Therapeutics Inc. is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases using its novel cell penetrating peptide technology platform.The company is seeking an experienced Associate Director/Director, Quality to support the Quality organization in leading...
Global Pharmacovigilance Operations Contractor
3 months ago
Job Summary: Vir Biotechnology is looking for a Senior Manager, Pharmacovigilance Operations Contractor to help support the global PV Operations team. This role is located in San Francisco and will report to the Director of PVRM Operations. RESPONSIBILITIES AND LEARNING OPPORTUNITIES: Support the daily functioning of the Pharmacovigilance Operations Department. Assist with compliance with standard operating procedures (SOPs), regulatory safety, and pharmacovigilance in compliance with US and global regulations. Responsible for operational tasks related to electronic Trial Master File documents, including quality review, organization, maintenance, and storage following study procedures. Help with Pharmacovigilance mailbox (i.e. ensure all emails are processed, identify requests, ensure all emails are prioritized and organized as well as follow-up on outstanding deliverables). Perform quality review of individual case safety reports (ICSR). Help track submissions of ICSRs and aggregate safety reports (i.e. line listings, DSURs, PADERs, PSURs/PBRERs, IND Annual Reports, PADERs, etc.). Communicate with pharmacovigilance and clinical vendors for all pharmacovigilance operations activities. Participate in set-up of new clinical trials, including development of study-specific Safety Management Plans and Forms. Assist in writing and maintenance of Global PVRM and safety-related cross-functional SOPs and work instructions. Manage review of Safety Regulatory Intelligence within Global PVRM. Help with other activities and special projects. QUALIFICATIONS AND EXPERIENCE: RN/PharmD or similar degree with 5+ years of experience in drug safety/pharmacovigilance operations with broad exposure to Trial Master File (TMF) and ICSR activities. Working knowledge of domestic and international adverse event reporting regulations (ICH, EMA GPV, GCP, FDA, etc.). Experience in case management and case processing activities. Experience using ARGUS or other safety databases. Experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications. Experience writing SOPs. This is a Hybrid role and will require you to spend a certain number of days in our San Francisco office each week. The expected salary range for this position is $55.00 to 78.00/Hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. #J-18808-Ljbffr
