Ra/pv Quality Business Partner

1 semana atrás


Lisboa, Lisboa, Portugal Organon Tempo inteiro

Job Description:

Position Overview


In this role you will help improve and sustain global and local quality and compliance of regulatory affairs and pharmacovigilance activities for all products within the Organon portfolio of drugs, medical devices, and combination products that are commercialized or in development globally.


Responsibilities:

  • Simplify processes and systems, in collaboration with functional colleagues, to ensure the procedural frameworks governing RAaPV and GPSS activities are compliant and fit for purpose at Organon.
  • Ensure change control for all PV procedural documents, including robust impact analyses and training programs prior to implementation.
  • Support audit and inspection readiness of the RAaPV and GPSS organizations.
  • Perform root cause analysis and write CAPA plans associated with quality issues and audit/inspection findings, in collaboration with RAaPV and GPSS colleagues.
  • Review and approve procedural documents and associated training plans, ensuring proper change control.
  • Work directly with RAaPV and/or GPSS and other stakeholders to facilitate timely and proper execution of investigations of quality issues, including impact analysis and root cause analysis.
  • Develop datadriven reports of RAaPV and/or GPSS performance against a predefined set of quality
- or compliance-indicating metrics.

  • Participate in PVrelated inspections of Organon to ensure clear and concise information about the PV system is provided to inspectors.
  • Participate in regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact the Organon PV system.
  • Generate various documents (such as reports, presentations, or quality agreements) to support key quality management system activities

Requirements:

  • Bachelor's Degree or equivalent in a scientific or technical field related to the healthcare/pharmaceutical industry, or licensed Healthcare Professional degree (such as R.N., R.Ph., P.A.).
  • Knowledge of international laws and regulations governing the research and development, and safety surveillance, or drugs and medical devices.
  • Experience in medical device and/or pharmaceutical industry.
  • Knowledge and experience with quality management systems, change control, root cause analysis, and CAPA.
  • Understanding/experience with endtoend drug and/or medical device R&D and submission processes and systems.
  • 2+ years in jobs related to regulatory affairs or pharmacovigilance/safety.
  • Understanding/experience with audits and health authority inspections.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives.

We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.

We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.


Our Vision is clear:
A better and healthier every day for every woman.

Search Firm Representatives Please Read Carefully

Annualized Salary Range

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites


Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R519030
  • HR Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal HR Partner Tempo inteiro

    Detalhe da oferta:A HR Partner é uma empresa de Recrutamento Especializado, que trabalha diretamente com o cliente final. O nosso cliente é uma empresa multinacional líder no setor onde opera e numa ótica de crescimento está atualmente à procura de um HR Business Partner para integrar equipa em Lisboa.Descrição da Função: Gestão e desenvolvimento...

  • HR Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal International Business Consulting Tempo inteiro

    A IBC está a recrutar para empresa multinacional do setor financeiro localizada em LisboaHuman Resources Business Partner (M/F)Principais responsabilidades:Este profissional terá como principais responsabilidades agir como parceiro das diferentes Direções da organização e agir como facilitador entre a gestão de pessoas e o negócio. Deverá auscultar...

  • IT Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Pestana Hotel Group Tempo inteiro

    IT Business Partner (M/F) Lisboa:Cidade: LisboaIT Business Partner (M/F) Lisboa:MissionMake the bridge between the world of business and technology, understanding the specific goals of the overall business and individual departments and ensuring that those needs will be translated into technology requirements for IT development.Key Roles and Responsibilities...


  • Lisboa, Lisboa, Portugal Grünenthal Tempo inteiro

    Country:PortugalCity:LisbonDepartment:Corporate FunctionsJob ID:44074Job Grade:Hiring Manager: Silvia MorraceiraInternal Posting Date: 07/05/2024- Our Corporate Functions teams make sure everything at Grünenthal runs smoothly by bringing together people with a wide range of skills - from experts in finance, IT, HR, law and compliance through to business...


  • Lisboa, Lisboa, Portugal Scandinavian Tobacco Group Tobacco Service B.V. Tempo inteiro

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: SAP Business Partner Data Specialist JOB TITLE – SAP Business Partner Data Specialist LOCATION - Lisbon or Madrid HOURS - 40 hours ABOUT THE ROLE We have an exciting opportunity for an SAP Business Partner Data Specialist to join our Data Management team. As an SAP...


  • Lisboa, Lisboa, Portugal Fortrea Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • IT Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Pestana Group Tempo inteiro

    IT Business Partner (m/f) - Lisboa Mission Make the bridge between the world of business and technology, understanding the specific goals of the overall business and individual departments and ensuring that those needs will be translated into technology requirements for IT development. Key Roles and Responsibilities Liaising between the IT...


  • Lisboa, Lisboa, Portugal MSD Tempo inteiro

    Job Description:The Regulatory Affairs and Quality Assurance Specialist has as primary task to take care of the Quality Assurance and Regulatory Affairs activities of the RA Unit. The position is related to veterinary medicinal products.Role in the organizationThe Regulatory Affairs and Quality Assurance Specialist has contact with stakeholders inside and...

  • HR Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Foundever Tempo inteiro

    HR Business Partner - Lisbon, PortugalWe are excited to offer you the opportunity to join our team as an HR Business Partner. As an HR Business Partner, you will play a crucial role in leading the HR function to ensure development, engagement, motivation, and an exceptional Employee Experience.Your responsibilities as an HR Business Partner will...

  • People Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Indie Campers Tempo inteiro

    ABOUT USIndie Campers, the go-to campervan Marketplace, is on a mission of making road trips available to everyone. Thanks to its digital approach and customer-centric orientation, Indie Campers has developed a strong booking experience and high-quality road trips at affordable prices.With over one million nights rented through our travel platform, we have...

  • Hr Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Foundever Tempo inteiro

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Lisboa, Portugal, PT Email Share Share Share Share Share Job Description: Come and work with us. We are looking for a talented and accomplished HR Business Partner to lead the HR function to ensure the development, engagement, motivation and the best Employee...

  • hr business partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Randstad Tempo inteiro

    Our client is a multinational company, that is looking for a HR Business Partner.

  • Hr Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Shockvoyce Tempo inteiro

    We are looking for a competitive HR Business Partner to join our high calibre team at ShockVoyce in Lisboa.Growing your career as a Full Time HR Business Partner is a terrific opportunity to develop competitive skills.If you are strong in leadership, people management and have the right mindset for the job, then apply for the position of HR Business Partner...

  • Hr Senior Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Employment Pro Limited Tempo inteiro

    HR Business Partner | Talent Acquisition HR Business Partner | Talent Acquisition Senior Business Intelligence Developer (M/F) Senior IoT Business Data Analyst @ FP (M/F) Consultor Business Intelligence (M/F) Lisboa On We are SitelWe are a leading global outsourcing provider of multilingual customer experience management with 150 offices across 24...

  • HR Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal SYKES Tempo inteiro

    HR Business Partner - Lisbon, Portugal in Lisboa , Portugal HR Business Partner - Lisbon, PortugalLisboa, Portugal, PTJob Description:Come and work with us.We are looking for a talented and accomplished HR Business Partner to lead the HR function to ensure the development, engagement, motivation and the best Employee Experience.As an HR Business Partner ,...

  • Business Quality Manager

    1 semana atrás


    Lisboa, Lisboa, Portugal Teleperformance Tempo inteiro

    The Business Quality Manager is a subject-matter expert (SME) in Business Quality Improvement and its mission is to support the Quality in operations, monitor Business KPI ́s and reduce service defects, non-added value tasks, always looking for improvements opportunities in the projects under her/his umbrella. He is responsible to provide added value to the...

  • Business Quality Manager

    1 semana atrás


    Lisboa, Lisboa, Portugal Teleperformance Portugal Tempo inteiro

    The Business Quality Manager is a subject-matter expert (SME) in Business Quality Improvement and its mission is to support the Quality in operations, monitor Business KPI ́s and reduce service defects, non-added value tasks, always looking for improvements opportunities in the projects under her/his umbrella. He is responsible to provide added value to the...

  • Hr Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Randstad II - Prestação de Serviços, Limitada Tempo inteiro

    Our client is a multinational company, that is looking for a HR Business Partner.Responsabilidades chave Execution of HR development plans and follow-up according to defined targets; Supports communication channels and meetings to identify and provide answer to business needs; Budget follow-up, controlling and proposing effective preventive measures; Human...

  • It Business Partner

    1 semana atrás


    Lisboa, Lisboa, Portugal Pestana Management – Serviços De Gestão S.A Tempo inteiro

    Make the bridge between the world of business and technology, understanding the specific goals of the overall business and individual departments and ensuring that those needs will be translated into technology requirements for IT development. Key Roles and Responsibilities Liaising between the IT department and the executive level of PHG business units...


  • Lisboa, Lisboa, Portugal AstraZeneca Tempo inteiro

    Introduction to role: Are you passionate about driving business value using analytics? Do you have a strong understanding of business processes, customer needs, and challenges? If so, we have an exciting opportunity for you As a GBS Analytics Business Partner, you will be part of our growing GBS Analytics team, influencing the outlook of descriptive...