ziprecruiter
Sr. Manager / Associate Director, Drug Safety (Case Processing)
ziprecruiter, San Diego, California, United States, 92154
Job Description
Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match. Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved with disease. The depth and versatility of our RNAi technologies enable us to address conditions in virtually any therapeutic area and pursue disease targets not otherwise addressable by small molecules and biologics. We are leading the field in bringing the promise of RNAi to address diseases outside of the liver, with clinical pipeline including targets in the liver and lung, and a promising pipeline of preclinical candidates. Our corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need. The Position The Sr. Manager / Associate Director, Drug Safety will collaborate with cross-department teams to support safety operations during the setup of new clinical development programs. Responsibilities include oversight of safety activities with Arrowhead CRO vendors and partners, implementing safety reporting processes in compliance with global requirements, and monitoring adherence to internal SOPs related to drug safety and pharmacovigilance. Responsibilities
Lead case processing and support safety medical review, including generating queries to CROs for SAE case clarification and completion. Ensure consistency and accuracy in investigator causality assessments and source documentation. Participate in setting up new safety projects, including developing safety plans and system setup. Prepare and track PVAs/SDEAs with partners. Monitor compliance with safety activities as per PVA/SDEA agreements. Create and maintain Safety Management Plans and reports with vendors. Review vendor scope and assist with study-level budgets. Oversee vendor safety activities, including KPI tracking and process improvements. Manage SAE reconciliation between databases and oversee data clean-up and migration. Oversee submission activities for ICSRs and aggregate reports. Collaborate on TMF Safety document filing and review. Manage safety database operations, ensuring timely SAE reporting and compliance. Coordinate with vendors for safety document filing and safety reporting activities. Support safety operations team and ensure quality and compliance in pharmacovigilance activities. Manage safety vendors, CROs, and external partners. Analyze events for expedited safety reporting in clinical studies. Track and monitor cases and vendor deliverables for quality and timeliness. Provide case management support to safety medical monitors. Assist in developing SOPs and procedural documents. Review SAE/SUSAR case processing and support safety monitoring plans. Prepare safety data for DSC and DSMB meetings. Ensure SAE reconciliation with vendors and CROs. Liaise with other departments for safety data and reporting. Participate in inspection readiness activities and document safety activities for audits. Coordinate with regulatory bodies for safety reporting requirements. Support review and development of clinical trial documents related to safety. Monitor safety signals and trends from post-marketing data. Maintain safety documentation and manage safety mailboxes. Support quality assurance activities and compliance with safety regulations. Produce safety data outputs for regulatory reports and analyses. Manage the safety/Pharmacovigilance QMS and SOPs. Assist with safety database updates, testing, and configuration. Perform system upgrades and participate in disaster recovery tests. Support drug safety listings and data management tasks. Requirements: BS/BA in a health-related field (RN/BSN preferred) with 8+ years in pharma or CRO. 5-10 years experience in drug safety operations, pharmacovigilance, or related fields. Prior experience with Safety/Pharmacovigilance operations required. Strong knowledge of case management, ARGUS or similar safety databases, and MedDRA/WHO coding. Experience preparing aggregate safety reports (DSURs, PBRERs, etc.). Proficiency with safety databases (Argus, ArisG, etc.) and knowledge of ICH E2B guidelines. Excellent organizational skills and ability to multitask effectively. California pay range $150,000—$185,000 USD Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US. California Applicant Privacy Policy
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Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match. Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved with disease. The depth and versatility of our RNAi technologies enable us to address conditions in virtually any therapeutic area and pursue disease targets not otherwise addressable by small molecules and biologics. We are leading the field in bringing the promise of RNAi to address diseases outside of the liver, with clinical pipeline including targets in the liver and lung, and a promising pipeline of preclinical candidates. Our corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need. The Position The Sr. Manager / Associate Director, Drug Safety will collaborate with cross-department teams to support safety operations during the setup of new clinical development programs. Responsibilities include oversight of safety activities with Arrowhead CRO vendors and partners, implementing safety reporting processes in compliance with global requirements, and monitoring adherence to internal SOPs related to drug safety and pharmacovigilance. Responsibilities
Lead case processing and support safety medical review, including generating queries to CROs for SAE case clarification and completion. Ensure consistency and accuracy in investigator causality assessments and source documentation. Participate in setting up new safety projects, including developing safety plans and system setup. Prepare and track PVAs/SDEAs with partners. Monitor compliance with safety activities as per PVA/SDEA agreements. Create and maintain Safety Management Plans and reports with vendors. Review vendor scope and assist with study-level budgets. Oversee vendor safety activities, including KPI tracking and process improvements. Manage SAE reconciliation between databases and oversee data clean-up and migration. Oversee submission activities for ICSRs and aggregate reports. Collaborate on TMF Safety document filing and review. Manage safety database operations, ensuring timely SAE reporting and compliance. Coordinate with vendors for safety document filing and safety reporting activities. Support safety operations team and ensure quality and compliance in pharmacovigilance activities. Manage safety vendors, CROs, and external partners. Analyze events for expedited safety reporting in clinical studies. Track and monitor cases and vendor deliverables for quality and timeliness. Provide case management support to safety medical monitors. Assist in developing SOPs and procedural documents. Review SAE/SUSAR case processing and support safety monitoring plans. Prepare safety data for DSC and DSMB meetings. Ensure SAE reconciliation with vendors and CROs. Liaise with other departments for safety data and reporting. Participate in inspection readiness activities and document safety activities for audits. Coordinate with regulatory bodies for safety reporting requirements. Support review and development of clinical trial documents related to safety. Monitor safety signals and trends from post-marketing data. Maintain safety documentation and manage safety mailboxes. Support quality assurance activities and compliance with safety regulations. Produce safety data outputs for regulatory reports and analyses. Manage the safety/Pharmacovigilance QMS and SOPs. Assist with safety database updates, testing, and configuration. Perform system upgrades and participate in disaster recovery tests. Support drug safety listings and data management tasks. Requirements: BS/BA in a health-related field (RN/BSN preferred) with 8+ years in pharma or CRO. 5-10 years experience in drug safety operations, pharmacovigilance, or related fields. Prior experience with Safety/Pharmacovigilance operations required. Strong knowledge of case management, ARGUS or similar safety databases, and MedDRA/WHO coding. Experience preparing aggregate safety reports (DSURs, PBRERs, etc.). Proficiency with safety databases (Argus, ArisG, etc.) and knowledge of ICH E2B guidelines. Excellent organizational skills and ability to multitask effectively. California pay range $150,000—$185,000 USD Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US. California Applicant Privacy Policy
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