Pharmacovigilance Compliance and Safety Operations

5 maanden geleden

Utrecht, Nederland BAXTER Voltijd

**Vantive: A New Company Built On Our Legacy**

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.**Summary**:
This position is a member of Global Patient Safety -Global Pharmacovigilance Compliance and Safety Operations. This role encompasses the management of Safety Operations, PV Technology and Data Management supporting Kidney Co.’s products globally. In addition, the manager works closely with the Director and the compliance team to support Quality Management System (QMS), compliance activities and PV inspections/audits worldwide.

The manager ensures that Safety Operations are appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to pharmacovigilance.

**What you'll be doing...**:
**Safety Operations**
- Ensure that pharmacovigilance daily operations, including adverse event case processing, global literature search and submission of ICSR to Health Authorities worldwide comply with regulations.
- Manage global vendor in charge of the Global Safety Database to convert GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solution.
- Manage global vendor in charge of the Global Safety Database ensuring that any quality deviation and or miss of KPIs is properly addressed and a CAPA is initiated if needed.
- Determine root causes of nonconformance and assist in developing effective problem solution strategies to ensure compliance with safety information reporting to HAs worldwide.

**GPS PV Audit and Inspection readiness**
- Responsible and accountable for leading and or support in responding to PV audits/inspections (including North America) and for opening corrective actions/preventive actions (CAPAs) for Safety Operations activities.

**PV System Compliance and GPS QMS**:

- has oversight responsibility of GPS QMS documents management and training processes, for Safety Operations, PV Technology and Data Management activities, including strategy and compliance, use of BAXU, GPS training assignments and training metric reports.
- has oversight for any agreement withs vendors related to Safety Operations and PV Technology and Data Management activities

**What you'll bring...**:

- Master’s Degree in life science with at least 5 years in safety vigilance/Pharmacovigilance
- Working experience with team management
- Excellent interpersonal skills that encourage teamwork
- Ability to work under strict deadlines and changing priorities and ability to multitask and prioritize changing workload for self and others
- Problem Solving
- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with mínimal assistance
- Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU Regulations
- Ability to interact effectively in a multifunctional and multicultural team setting.
- Experience working within a quality system to develop and optimize processes.
- Experience on PV vendor management.
- Ability to collaborate effectively in a complex matrix organization.
- Excellent analytical and problem-solving skills.
- Mature personality with excellent leadership and interpersonal skills
- Leadership experience in managing direct and shared resources, some at a geographic distance.
- Cultural sensitivity, patient but persuasive, cultural fit with values.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

134837

  • (Associate) Director, Global Drug Safety

    6 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Associate, Lab Safety

    6 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Hydrogen Laboratory Safety and Operations

    2 maanden geleden

    Utrecht Oost, Nederland Universiteit Utrecht Voltijd

    Utrecht University's Hydrogen Laboratory is a research facility at the forefront of hydrogen-related projects in the Netherlands. Our focus on system-scale hydrogen production and utilisation drives innovative research aimed at addressing global energy challenges. **Your job**: As a Laboratory Coordinator, you will play an important role in supporting...

  • Operations Manager

    1 maand geleden

    Utrecht, Nederland BOSS Energy Voltijd

    Operations Manager- LOCATION Netherlands, Utrecht - INDUSTRY Hydrogen - DATE POSTED 25 October, 2024 - CONTRACT Permanent **Project Engineer - Hydrogen Refuelling Stations (HRS)** **Job Overview**: The Asset Engineer is responsible for managing the operations of Hydrogen Refuelling Stations (HRS) across Europe, ensuring they meet safety, regulatory, and...

  • Operations Director

    3 weken geleden

    Utrecht, Utrecht, Nederland BOSS Energy Voltijd

    Job Title: Operations ManagerJob Overview:BOSS Energy is seeking an Operations Manager to oversee the management of Hydrogen Refuelling Stations (HRS) across Europe, ensuring they meet safety, regulatory, and operational standards. This role is crucial in supporting the company's goal of developing 100 hydrogen stations by 2033, promoting sustainability...

  • Hydrogen Operations Manager

    1 maand geleden

    Utrecht, Utrecht, Nederland BOSS Energy Voltijd

    Job Overview:The Asset Engineer is responsible for managing the operations of Hydrogen Refuelling Stations (HRS) across Europe, ensuring they meet safety, regulatory, and operational standards. You will contribute to company goal of developing 100 hydrogen stations by 2033, supporting sustainability efforts in the mobility sector.Key Responsibilities:-...

  • Hydrogen Refuelling Stations Operations Manager

    1 maand geleden

    Utrecht, Utrecht, Nederland BOSS Energy Voltijd

    Job Overview:The Asset Engineer is responsible for managing the operations of Hydrogen Refuelling Stations (HRS) across Europe, ensuring they meet safety, regulatory, and operational standards. This role contributes to the company's goal of developing 100 hydrogen stations by 2033, supporting sustainability efforts in the mobility sector.Key...

  • Hydrogen Refuelling Station Operations Specialist

    3 weken geleden

    Utrecht, Utrecht, Nederland BOSS Energy Voltijd

    As a skilled Asset Engineer, you will oversee the day-to-day operations of Hydrogen Refuelling Stations across Europe, ensuring they meet safety, regulatory, and operational standards. Your role will be crucial in supporting the company's goal of developing 100 hydrogen stations by 2033, contributing to sustainability efforts in the mobility sector.Key...

  • R&D Food Safety and Quality Assurance Intern

    4 weken geleden

    Utrecht, Utrecht, Nederland JACOBS DOUWE EGBERTS Voltijd

    R&D Food Safety Intern Role OverviewAs R&D Food Safety Intern, you will contribute to the evaluation of food safety and quality of plant-based beverages at our international headquarters in Utrecht. Your primary objective will be to identify food safety risks and develop mitigation strategies.Key Responsibilities:Conduct literature reviews on food safety...

  • Embedded Safety Specialist

    3 weken geleden

    Utrecht, Utrecht, Nederland TMC Voltijd

    About the RoleWe are seeking an experienced Functional Safety Engineer to work on safety systems for autonomous vehicles. The ideal candidate will have a background in Automotive, Aerospace, Embedded Systems, or Mechanical Engineering and be proficient in Codesys programming.Key ResponsibilitiesThe successful candidate will be responsible for designing and...

  • Process Safety Engineer

    6 maanden geleden

    Utrecht, Nederland Paltrock HSE Voltijd

    JOB DESCRIPTION Als Process safety engineer bij Paltrock word je ingezet voor project en advies opdrachten om ervoor te zorgen dat de procesveiligheid van onze klanten voldoet aan de hoogste normen en standaarden. Verantwoordelijkheden: Participate in PHA, HAZOP, MOC and TRA procedures; Review and advise about process safety; Lead or participate...

  • Financial Operations Manager

    2 weken geleden

    Utrecht, Utrecht, Nederland Carrier Voltijd

    Carrier, a global leader in business solutions, is seeking a highly skilled Financial Operations Manager to join its team. With an estimated annual salary of $120,000 - $180,000, this role offers a unique opportunity for career advancement and professional growth.Job Description:The Financial Operations Manager will play a critical role in ensuring the...

  • Asset Operations Manager

    3 weken geleden

    Utrecht, Nederland SolarEnergyWorks Voltijd

    **Location**: Utrecht/Hybrid Working **Job Title**:Asset Operations Manager **Full-time/Part-time/Internship**: Full time - 40 hours/week **Department**: EPC & Asset Operations Ampyr Solar Europe (ASE) is a dynamic and rapidly expanding renewable energy business transitioning to a fully integrated Independent Power Producer (IPP). With 6 assets in...

  • Food Safety Expertise Development Intern

    5 dagen geleden

    Utrecht, Utrecht, Nederland JACOBS DOUWE EGBERTS Voltijd

    Internship Opportunity at JACOBS DOUWE EGBERTSWe are seeking a motivated and detail-oriented Food Safety Expertise Development Intern to join our R&D Food Quality team. This internship provides an exceptional opportunity to gain hands-on experience in food safety assessment, risk analysis, and protocol development.About the RoleThis is a 5-month internship...

  • Safety and Sustainability Expert

    7 dagen geleden

    Utrecht, Utrecht, Nederland DEME Group Voltijd

    At DEME Group, we pioneer the cutting edge of technology in a rapidly changing world. Our activities span dredging, off-shore, infrastructure, and environmental sectors, providing tailor-made solutions for customers' projects. We help them be safer, more cost-effective, and sustainable.Your ResponsibilitiesIn this QHSE role, you will assist project and...

  • Safety Engineer

    5 dagen geleden

    Utrecht, Utrecht, Nederland TMC Voltijd

    We are seeking a skilled Functional Safety Engineer to join our team in the Netherlands. As a key member of our Industrial Automation department, you will work on safety systems for autonomous vehicles.About the Role:Key ResponsibilitiesDesign and develop safety-critical systems for autonomous vehiclesWork with cross-functional teams to ensure compliance...

  • Offshore Wind Development Health, Safety and Environment Expert

    5 dagen geleden

    Utrecht, Utrecht, Nederland RWE AG Voltijd

    Job OverviewRWE AG is seeking a highly experienced HSE Advisor to join our Offshore Wind Development team in the Netherlands. As a key member of the team, you will play a vital role in ensuring the health, safety, and environmental management of our offshore development projects.About the RoleThis is a full-time, permanent position that requires immediate...

  • Chief Security and Compliance Officer

    2 dagen geleden

    Utrecht, Utrecht, Nederland Futureproof Group Voltijd

    Bezig met het opzetten en uitbouwen van onze veiligheid?\Hoe ziet de functie eruit:\Als Chief Security and Compliance Officer speel je een cruciale rol in het waarborgen van de integriteit van onze activiteiten en het voldoen aan alle toepasselijke regelgeving. In deze nieuwe functie, die gepositioneerd is binnen de centrale organisatie die de business units...

  • Operations Manager Benelux

    1 dag geleden

    Utrecht, Nederland Arrow Electronics, Inc. Voltijd

    Position:Operations Manager BeneluxJob Description:ABOUT THE ROLEThe Operations Manager acts as a key contact point for internal and external matters relating to the efficient and successful operations of one or more country(ies). Additionally, this function is responsible for helping the local Management and the external stakeholders (customers and vendors)...

  • Nike - Sales Coach (Floor Manager)

    5 maanden geleden

    Utrecht, Nederland Retailors Netherlands B.V. Voltijd

    **Are you Ready?** The Coach’s mission is to ensure the success of the store by creating an environment that will provide a premium consumer and employee experience and implementing/executing programs to drive business results. The Coach is a natural leader and supports the Head Coach in the daily operations of the store. **ESSENTIAL DUTIES AND...