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Takeda Development Center Americas, Inc
Cambridge
Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA to provide global strategic leadership and expertise in risk management across therapeutic areas. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US. Full tim...
Job Source: Takeda Development Center Americas, IncTakeda 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 PharmaceuticalsTakeda
Boston, MA, United States
Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics. We nurture a culture that encourages disciplined r
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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
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Director/Senior Director, Program and Alliance Management Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease, and infectious disease. The company was founded by Flagship Pioneering on the belief that understanding the repertoire of T
Job Source: Repertoire Immune MedicinesONO PHARMA USA
Cambridge, MA, United States
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan. To develop human resources for appropriate business operat
Job Source: ONO PHARMA USAONO PHARMA USA
Cambridge, MA, United States
To promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately implemented based on the developed PV plan. To develop human resources for appropriate business operat
Job Source: ONO PHARMA USACBRE
Boston, MA, United States
VAS Quality & Risk Management Director Job ID 158433 Posted 26-Apr-2024 Service line Advisory Segment Role type Full-time Areas of Interest Valuations/Appraisal Location(s) Remote - US - Remote - US - United States of America Are you ready to start an exciting career with CBRE? About The Role: As a CBRE Quality & Risk Management (QRM
Job Source: CBREBoston, 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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