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Takeda Pharmaceuticals
Boston, MA, United States
Takeda Pharmaceuticals Director, PV Risk Management Boston , Massachusetts Apply Now By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further at
Job Source: Takeda PharmaceuticalsPathAI
Boston, MA, United States
Director of Biopharma Alliance Management PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapie
Job Source: PathAINimbus Therapeutics, Inc.
Boston, MA, United States
Senior Director, Project Management & Alliance Management Nimbus has an outstanding opportunity for a Senior Director of Project Management & Alliance Management to join our team. This individual will manage key projects within preclinical/development in the therapeutic areas of oncology, immunology / inflammation, and metabolic diseases. You wil
Job Source: Nimbus Therapeutics, Inc.Nimbus Therapeutics
Boston, MA, United States
Nimbus has an outstanding opportunity for a Senior Director of Project Management & Alliance Management to join our team. This individual will manage key projects within preclinical/development in the therapeutic areas of oncology, immunology / inflammation, and metabolic diseases. You will report to our Vice President of Program Management, R&D St
Job Source: Nimbus TherapeuticsNimbus Therapeutics
Boston, MA, United States
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Boston, MA, United States
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Job Source: NextRNA TherapeuticsSkyhawk Therapeutics Inc
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Job Source: Skyhawk Therapeutics IncWave Life Sciences
Cambridge, MA, United States
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of
Job Source: Wave Life SciencesBoston, MA, United States
Position: Director, PV Quality and Alliance Management
Department: Pharmacovigilance
Reports to: Vice President, Pharmacovigilance
Location: Boston or Hybrid
Summary:
The Director, Pharmacovigilance (PV) Quality and Alliance Management will be responsible for leading PV Quality and alliance management activities in collaboration with internal and external key stakeholders. The position will build up PV quality system, develop and maintain PV agreements with license partners, provide quality oversight to safety service providers, provide PV training, and ensure inspection readiness for the PV function.
The Director, PV Quality and Alliance Management will report to VP, Pharmacovigilance.
The position will be based in Boston or hybrid with regular travel to Boston based on business needs.
Responsibilities:
Work with the VP, Pharmacovigilance to build up and maintain PV quality system, including performing gap analysis, preparing, and maintaining PV departmental policies, SOPs, and other procedural documents, and ensuring adequate job-related training of the PV team.
Provides oversight on PV vendors’ quality management systems including quality events management through resolution in collaboration with relevant functional team members.
Leads the development and maintenance of PV agreements with license partners.
Leads PV audits, inspections, and CAPA activities in collaboration with Quality Assurance team as required.
Leads and maintains oversight on PV documentation and record retention in PV department.
Leads the development and maintenance of Pharmacovigilance System Master File if required.
Ensures awareness and training of appropriate Company personnel and external groups on PV related policies and SOPs.
Provides PV guidance and support for interdepartmental and/or corporate initiatives.
Requirements:
Bachelor’s degree in life science is required.
5+ years of experience in the biotechnology or pharmaceutical industry with a focus on PV Quality for pre- and post-approval stage compounds; 2+ years of experience managing PV quality related to safety service outsourcing vendors and relationships, or equivalent experience with safety service providers. Experience with marketed and development stage oncology products is preferred.
2+ years of experience with PV agreement development and maintenance, including clinical trial, post-marketing, co-development, and co-commercialization types of alliances.
In-depth knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
Strong relationship building skills with ability to interact effectively in a multifunctional, multicultural, growing organization.
Strategic thinking, quality mindset, strong organizational and analytic skills, ability to gain commitment cross-functionally, collaborative spirit, excellent verbal, written communication skills, and attention to detail.
Proficient with Microsoft Office.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com .
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.
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Email Alert for Director, PV Quality and Alliance Management jobs in Boston, MA, United States
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