Director Of Pharmacovigilance Quality And Alliance Management
hace 1 mes
JOB TITLE: Director of Pharmacovigilance Quality and Alliance Management LOCATION: Boston or Remote JOB SUMMARY: The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV) team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology. This role involves overseeing the quality management of pharmacovigilance activities and managing strategic alliances with external partners. The Director will collaborate cross-functionally with clinical development, regulatory affairs, commercial teams, and external stakeholders to support the delivery of safe and effective oncology therapies. Pharmacovigilance Quality Management: Develop, implement, and maintain a comprehensive Pharmacovigilance Quality Management System (PV QMS) to ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH). Lead PV quality audits, including internal audits and audits of external partners/vendors, to ensure adherence to SOPs, regulatory requirements, and best practices. Oversee the preparation and execution of Corrective and Preventive Actions (CAPAs) following PV audits and inspections. Monitor and analyze pharmacovigilance processes, identifying areas for improvement and implementing necessary changes. Serve as the key point of contact for regulatory inspections related to pharmacovigilance and ensure audit readiness. Alliance Management: Manage relationships with external partners, including contract research organizations (CROs), pharmaceutical partners, and other vendors involved in pharmacovigilance activities. Negotiate and oversee agreements related to pharmacovigilance and quality responsibilities, ensuring clear communication and alignment of expectations. Monitor the performance of external partners to ensure compliance with contractual obligations and regulatory requirements. Facilitate regular meetings with alliance partners to discuss performance, issues, and opportunities for improvement. Strategic Leadership: Provide leadership and strategic direction for the Pharmacovigilance Quality and Alliance Management functions. Collaborate with senior leadership to align pharmacovigilance and quality initiatives with the company's overall business strategy. Represent Aveo Oncology in industry forums, conferences, and other external engagements related to pharmacovigilance and quality. Team Development and Management: Lead and mentor a team of pharmacovigilance and quality professionals, fostering a culture of continuous improvement and excellence. Ensure the ongoing professional development of team members, providing opportunities for training and career growth. Allocate resources effectively to meet departmental and company goals. PRINCIPAL DUTIES: Advanced degree in a scientific discipline is preferred. Minimum of 10 years of experience in pharmacovigilance, quality management, or a related field within the pharmaceutical or biotechnology industry. In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices. Proven experience in managing quality systems, conducting audits, and leading regulatory inspections. Strong alliance management experience, particularly in the context of pharmacovigilance or drug safety. Excellent leadership, communication, and negotiation skills. Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams. Strong analytical and problem-solving abilities. About AVEO: AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr
-
Director of Pharmacovigilance and Quality Assurance
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Summary: We are seeking a highly experienced Director of Pharmacovigilance Quality and Alliance Management to join our team at AVEO. The successful candidate will be responsible for ensuring the highest standards of drug safety and compliance within our organization. This role involves overseeing the quality management of pharmacovigilance activities and...
-
Director of Pharmacovigilance and Quality Assurance
hace 4 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Director of Pharmacovigilance and Quality AssuranceAt AVEO, we are seeking a highly skilled Director of Pharmacovigilance and Quality Assurance to join our team. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the highest standards of drug safety and compliance within our organization.Key...
-
Director, Pharmacovigilance And Drug Safety
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoDirector, Pharmacovigilance and Drug Safety (Operations & Compliance) Boston, MA, USA Req #265 Sunday, May 5, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...
-
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Director, Pharmacovigilance and Drug SafetyWe are seeking a highly experienced Director, Pharmacovigilance and Drug Safety to join our team. This critical leadership role will be responsible for establishing, maintaining, and overseeing procedures and systems to ensure adherence to local and international regulatory requirements for the...
-
Director, Pharmacovigilance And Drug Safety
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoDirector, Pharmacovigilance and Drug Safety (Safety Science) Boston, MA, USA Req #259 Friday, July 12, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological...
-
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoAbout the RoleWe are seeking a highly skilled Director, Pharmacovigilance and Drug Safety to join our team. This key leadership position will be responsible for establishing, maintaining, and overseeing procedures and systems to ensure adherence to local and international regulatory requirements for the collection, processing, and reporting of safety...
-
Vice President, Head Of Safety
hace 3 meses
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoVice President, Head of Safety & Pharmacovigilance About the Company Pioneering biotechnology company IndustryBiotechnology TypePrivately Held About the Role The Company is seeking a VP, Head of Safety and Pharmacovigilance to play a pivotal role in the organization's commitment to patient safety and the integration of safety into all aspects of the drug...
-
Head of Global Clinical and Safety Quality Compliance
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Biospace, Inc. A tiempo completoJob Title: Head of Global Clinical and Safety Quality ComplianceAbout the role:Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting clinical research, pharmacovigilance, and medical activities across the enterprise.Main Responsibilities:Provides quality...
-
Associate Director, Alliance Management- Government
hace 4 semanas
Puerto Diablo Barrio, Puerto Rico Ginkgo Bioworks A tiempo completoJob SummaryWe are seeking an experienced Associate Director, Alliance Management- Government to join our Government Business Generation team at Ginkgo Bioworks. As a key member of our team, you will be responsible for managing and executing government-funded projects, building and maintaining strategic partnerships with government agencies, and driving...
-
Head of Clinical and Safety Quality Compliance
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Biospace, Inc. A tiempo completoJob Title: Head of Clinical and Safety Quality ComplianceAt Biospace, Inc., we are seeking a highly skilled and experienced professional to lead our Clinical and Safety Quality Compliance team. As the Head of Clinical and Safety Quality Compliance, you will be responsible for providing quality oversight of our clinical research, pharmacovigilance, and...
-
Director, Utilization Management
hace 1 mes
Puerto Diablo, Puerto Rico Commonwealth Care Alliance A tiempo completoWhy This Role is Important to Us:The Director of Utilization Management leads and manages all utilization management (UM) functions for physical health services and long term services and supports to ensure achievement of business results while maintaining compliance with all contract requirements, state and federal regulatory requirements and all applicable...
-
Vice President, Clinical Safety
hace 3 meses
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoVice President, Clinical Safety & Pharmacovigilance About the Company Prominent biotechnology (BioTech) organization accelerating evidence-based mental health solutions IndustryBiotechnology TypePrivately Held About the Role The Vice President, Clinical Safety & Pharmacovigilance will be responsible for leading and overseeing the end-to-end safety and...
-
Director Of Quality And Safety
hace 1 mes
Puerto Diablo, Puerto Rico Boston Medical Center A tiempo completoThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
-
Director Of Quality And Safety
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
-
Utilization Management Director
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Commonwealth Care Alliance A tiempo completoJob DescriptionThe Director of Utilization Management is a key leadership role responsible for overseeing the effective management of healthcare services for physical health services and long-term services and supports. This position requires strong leadership and management skills, as well as expertise in healthcare operations and management.Key...
-
Director Of Quality
hace 3 meses
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoDirector of Quality About the Company Influential provider of web-based software for military planning & collaboration IndustryComputer Software TypePrivately Held, VC-backed Founded2019 Employees201-500 Funding$26-$50 million Categories Information TechnologyMilitaryProductivity ToolsSoftwareInformation Technology & ServicesComputer...
-
Clinical Quality Compliance Director
hace 4 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completopbAbout the Role:/bbrAs the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensure the...
-
Sales Executive
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoRole Overview: Jobleads-Us is seeking a highly motivated Sales Executive to play a key role in selling industry-leading drug safety and pharmacovigilance software solutions to pharmaceutical and biotech companies.Key Responsibilities:Develop and execute strategic sales plans to achieve assigned quotas.Identify and qualify new leads within the pharmaceutical...
-
Manager, Utilization Management
hace 1 mes
Puerto Diablo, Puerto Rico Commonwealth Care Alliance A tiempo completoWhy This Role is Important to Us:Commonwealth Care Alliance's (CCA) Clinical Effectiveness (Authorization) Unit is primarily responsible for the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services,procedures, and facilities under the provisions of CCA's benefits plan.The Manager, Utilization Management is...
-
Associate Director, Clinical Quality Compliance
hace 4 semanas
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoJob Title: Associate Director, Clinical Quality ComplianceLocation: Cambridge, MAAbout the role:As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state...
