Arrowhead Pharmaceuticals, Inc
Sr. Manager, Drug Safety & Pharmacovigilance Quality Assurance
Arrowhead Pharmaceuticals, Inc, San Diego, California, United States, 92189
Sr. Manager, Drug Safety & Pharmacovigilance Quality Assurance
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that 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.The PositionThe Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with PV and QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting and CAPA development, monitor quality and compliance.ResponsibilitiesProvide strategic guidance and leadership to the pharmacovigilance quality assurance teamDevelop and implement a comprehensive quality assurance strategy aligned with organizational goalsDevelop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/proceduresProactively provide Good Pharmacovigilance Practice (GVP) support for clinical and commercial activities to protect patient safety and well-being, maintain data integrity, and support implementation of Quality SystemsMonitor industry trends, regulatory changes, and best practices to ensure continuous improvement of quality assurance processesLead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activitiesEnsure that SOPs are consistent with current regulations, guidelines, and industry standardsManage a team of quality assurance professionals, including training, mentoring, and performance evaluationsFoster a collaborative and high-performance work environment to achieve departmental objectivesConduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirementsCollaborate with internal audit teams and external partners during regulatory inspections and auditsDevelop and implement key quality metrics to assess the effectiveness of pharmacovigilance processesPrepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvementCollaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities. Identify areas of potential risk and implement strategies to mitigate them proactivelyDrive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activitiesEngage with stakeholders to solicit feedback and implement process enhancementsMonitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV systemRequirements:Degree in pharmacy, life sciences, or a related fieldMinimum of 8 years of experience in pharmacovigilance or drug safety, with 8-10 years in a quality assurance or compliance roleStrong understanding of global pharmacovigilance regulations, guidelines, and industry best practicesProven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staffExcellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholdersDetail-oriented with strong analytical and problem-solving capabilitiesProficiency in using pharmacovigilance databases and softwareTravel 30%Preferred:Experience in conducting internal audits and managing regulatory inspectionsArrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company.
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Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that 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.The PositionThe Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with PV and QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting and CAPA development, monitor quality and compliance.ResponsibilitiesProvide strategic guidance and leadership to the pharmacovigilance quality assurance teamDevelop and implement a comprehensive quality assurance strategy aligned with organizational goalsDevelop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/proceduresProactively provide Good Pharmacovigilance Practice (GVP) support for clinical and commercial activities to protect patient safety and well-being, maintain data integrity, and support implementation of Quality SystemsMonitor industry trends, regulatory changes, and best practices to ensure continuous improvement of quality assurance processesLead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activitiesEnsure that SOPs are consistent with current regulations, guidelines, and industry standardsManage a team of quality assurance professionals, including training, mentoring, and performance evaluationsFoster a collaborative and high-performance work environment to achieve departmental objectivesConduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirementsCollaborate with internal audit teams and external partners during regulatory inspections and auditsDevelop and implement key quality metrics to assess the effectiveness of pharmacovigilance processesPrepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvementCollaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities. Identify areas of potential risk and implement strategies to mitigate them proactivelyDrive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activitiesEngage with stakeholders to solicit feedback and implement process enhancementsMonitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV systemRequirements:Degree in pharmacy, life sciences, or a related fieldMinimum of 8 years of experience in pharmacovigilance or drug safety, with 8-10 years in a quality assurance or compliance roleStrong understanding of global pharmacovigilance regulations, guidelines, and industry best practicesProven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staffExcellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholdersDetail-oriented with strong analytical and problem-solving capabilitiesProficiency in using pharmacovigilance databases and softwareTravel 30%Preferred:Experience in conducting internal audits and managing regulatory inspectionsArrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company.
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