Director of Pharmacovigilance

3 weeks ago


Étreux, Hauts-de-France, United States Bayer Full time
About the Role

Bayer's Senior Clinical Leader will be responsible for leading the company's pharmacovigilance efforts, ensuring compliance with regulatory requirements and developing strategies to mitigate risk to patients. The ideal candidate will have a strong background in clinical medicine, pharmacovigilance, and oncology, with experience in team leadership and submissions.

Responsibilities:

  1. Develop and implement pharmacovigilance strategies to ensure compliance with regulatory requirements
  2. Lead cross-functional teams to develop and review safety-related documents
  3. Collaborate with external bodies, including regulatory agencies and advisory boards
  4. Provide expert advice on benefit-risk management and risk communication

Requirements:

  • MD degree or equivalent
  • Deep knowledge of pharmacovigilance, oncology, and regulatory requirements
  • Significant experience in submissions and regulatory interactions
  • Strong leadership and collaboration skills

Benefits: Competitive salary, comprehensive benefits package, and bonus opportunities.



  • Étreux, Hauts-de-France, United States Page Mechanical Group, Inc. Full time

    Job Overview:At Page Mechanical Group, Inc., we are seeking a highly skilled Pharmacovigilance Director to oversee Global Safety across all marketed products and pipeline assets. This critical role plays an integral part in building a Pharmacovigilance infrastructure for our rapidly growing biotech company.Key Responsibilities:Ensure global Pharmacovigilance...


  • Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    About the RoleEstimated Salary: $180,000 - $220,000 per year. We are seeking an experienced Director of Pharmacovigilance Quality and Alliance Management to join our team at Page Mechanical Group Inc.This is a pivotal role that involves overseeing the quality management of pharmacovigilance activities and managing strategic alliances with external partners....


  • Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    Job Summary">The Director of Pharmacovigilance Quality will oversee the quality management of pharmacovigilance activities, ensuring compliance with global regulatory requirements. This role involves developing and implementing a comprehensive Pharmacovigilance Quality Management System (PV QMS) and leading PV quality audits.">About the Role">We are seeking...


  • Étreux, Hauts-de-France, United States Klein Hersh International Full time

    Klein Hersh International is seeking a Senior Director, Pharmacovigilance and Risk Management, to play a key role in ensuring the company's continued success in developing innovative therapeutics.This individual will be responsible for leading the company's PV and risk management function, ensuring compliance with global regulatory standards, and providing...


  • Étreux, Hauts-de-France, United States Aveo Pharmaceuticals Inc Full time

    Job Summary">The Senior Director, Pharmacovigilance Operations will lead the overall PV operations, encompassing adverse event collection, processing, and reporting from various sources. The role involves vendor management, PV quality management, and ensuring regulatory compliance across the entire portfolio in clinical development and post-approval...


  • Étreux, Hauts-de-France, United States Klein Hersh International Full time

    Klein Hersh International is a pioneering biotechnology company committed to developing innovative therapeutics for cancer treatment. The organization's vision is to revolutionize the healthcare industry through cutting-edge research and development.Job OverviewThis senior leadership role is pivotal in ensuring the company remains at the forefront of patient...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the TeamTakeda's Patient Safety and Pharmacovigilance (PSPV) team is responsible for overseeing the safety of our products and ensuring that they meet the highest standards of quality and safety. We are seeking a highly skilled Senior Medical Director, Pharmacovigilance to join our team in Gastrointestinal and Inflammation (GI2).About the RoleYou will...


  • Étreux, Hauts-de-France, United States Aveo Pharmaceuticals Inc Full time

    Job DescriptionThe Senior Director, Pharmacovigilance Operations will play a critical role in ensuring pharmacovigilance operational excellence and regulatory compliance for our entire portfolio in clinical development and post-approval stages. This role involves leading a team of pharmacovigilance professionals and collaborating internally and externally to...


  • Étreux, Hauts-de-France, United States AVEO Oncology Full time

    About the Role:We are seeking an experienced Oncology Director to lead our Pharmacovigilance and Compliance team. This is a critical role that requires strong leadership skills, expertise in pharmacovigilance and compliance, and a deep understanding of oncology.Key Responsibilities:Develop and Implement PV Strategy: Develop and implement the strategy for...


  • Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    About the Opportunity">Aveo Oncology is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. We are seeking an experienced professional to join our Pharmacovigilance Quality team as a Director.">Key Skills and Qualifications">">Advanced degree in a scientific...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Company Ltd Full time

    About Our TeamTakeda Pharmaceutical Company Ltd is a leading global pharmaceutical company committed to bringing better health and a brighter future to people around the world. We strive to make a positive impact on society through our innovative products, services, and partnerships.We are currently seeking an experienced Medical Safety Sciences Head to join...


  • Étreux, Hauts-de-France, United States Blackwomenintech Full time

    **Job Description**We are looking for a seasoned Medical Director, Global Safety who can drive our pharmacovigilance efforts and ensure the highest standards of safety in our products. The ideal candidate will have a strong background in medicine, preferably with a focus on neuroscience, psychiatry, immunology, or rare diseases.The successful candidate will...


  • Étreux, Hauts-de-France, United States Veeva Systems Full time

    Veeva Systems is a pioneer in industry cloud, driving the transformation of life sciences companies. As one of the fastest-growing SaaS companies in history, we have surpassed $2 billion in revenue with extensive growth potential ahead.About VeevaWe are driven by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just...


  • Étreux, Hauts-de-France, United States Klein Hersh International Full time

    Job OverviewKlein Hersh International is seeking an experienced professional to lead the development of its pharmacovigilance and risk management function.The ideal candidate will have a deep understanding of global safety regulations, including FDA safety regulations, ICH Guidelines, EU GVP, and other international standards.Key ResponsibilitiesLead the...


  • Étreux, Hauts-de-France, United States Leading Age Full time

    We are seeking a highly experienced Senior Medical Director to lead our clinical development efforts in dermatology. This individual will be responsible for developing and implementing product development plans, leading clinical trial strategy, and ensuring compliance with regulatory requirements.The ideal candidate will have a strong background in...


  • Étreux, Hauts-de-France, United States Klein Hersh International Full time

    We are seeking a highly skilled Clinical Director for Global Health to lead our Clinical Safety team. In this role, you will be responsible for ensuring the highest standards of quality and compliance while driving integrated safety signal identification, rapid signal refinement/validation, and lifecycle risk management planning. Your expertise in...


  • Étreux, Hauts-de-France, United States Aveo Pharmaceuticals Inc Full time

    Job SummaryThe Senior Director, Pharmacovigilance Operations will oversee the overall pharmacovigilance operations, including adverse event collection, processing, and reporting from various sources. This role involves vendor management and quality assurance for the entire portfolio in clinical development and post-approval stages.This position leads a team...


  • Étreux, Hauts-de-France, United States Veeva Systems Full time

    About UsVeeva Systems is a leader in the life sciences industry cloud, empowering companies to bring therapies to patients faster. With a strong commitment to innovation and customer satisfaction, we strive to create a lasting impact on the lives of those affected by diseases.Our company culture is built around four core values: Do the Right Thing, Customer...


  • Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    Job SummaryThe Director of Pharmacovigilance Quality and Alliance Management will lead the development, implementation, and maintenance of a comprehensive Pharmacovigilance Quality Management System (PV QMS). This system must ensure compliance with global regulatory requirements, such as those set by the FDA, EMA, and ICH.You will oversee the preparation and...


  • Étreux, Hauts-de-France, United States Takeda Full time

    About the PositionThe Director of Risk Management will lead the development and implementation of a comprehensive risk management strategy to ensure compliance with regulatory requirements worldwide. This individual will provide expert guidance on risk assessment, risk minimization, and benefit-risk evaluation for products in clinical development and...