Empleos actuales relacionados con PV Benefit-Risk Safety Writer - Madrid, Madrid - Baxter

  • PV Benefit-Risk Safety Specialist

    hace 1 mes

    Madrid, Madrid, España Baxter A tiempo completo

    Transforming Kidney Care with BaxterBaxter is embarking on a groundbreaking journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive. This bold move will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis, providing best-in-class care to those we serve.At Vantive, we're seeking a PV Benefit-Risk...

  • PV Benefit-Risk Safety Specialist

    hace 1 mes

    Madrid, Madrid, España Baxter A tiempo completo

    Transforming Kidney Care with BaxterBaxter is embarking on a groundbreaking journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive. This bold move will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis, providing best-in-class care to those we serve.At Vantive, we're seeking a PV Benefit-Risk...

  • PV Benefit-Risk Safety Specialist

    hace 3 semanas

    Madrid, Madrid, España Baxter A tiempo completo

    Transforming Patient Safety with BaxterBaxter is revolutionizing kidney care and other vital organ support by separating our ~$5B Kidney Care segment into a standalone company, Vantive. As a PV Benefit-Risk Safety Writer, you will play a pivotal role in ensuring the safety and compliance of our pharmaceutical products worldwide.Key Responsibilities:Author...

  • PV Benefit-Risk Safety Specialist

    hace 3 semanas

    Madrid, Madrid, España Baxter A tiempo completo

    Transforming Patient Safety with BaxterBaxter is revolutionizing kidney care and other vital organ support by separating our ~$5B Kidney Care segment into a standalone company, Vantive. As a PV Benefit-Risk Safety Writer, you will play a pivotal role in ensuring the safety and compliance of our pharmaceutical products worldwide.Key Responsibilities:Author...

  • PV Benefit-Risk Safety Specialist

    hace 6 días

    Madrid, Madrid, España Baxter A tiempo completo

    Vantive: Revolutionizing Kidney Care and BeyondBaxter, a pioneering company, is embarking on a journey to separate its $5B Kidney Care segment into a standalone entity, Vantive. This new company will build upon Baxter's nearly 70-year legacy in acute therapies and home and in-center dialysis to provide world-class care to those in need.At Vantive, you will...

  • PV Benefit-Risk Safety Specialist

    hace 3 semanas

    Madrid, Madrid, España Baxter A tiempo completo

    Vantive: A New Era in Kidney CareBaxter is embarking on a transformative journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive. This new entity will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to those we serve. We believe Vantive will not only solidify our...

  • Deputy Local Safety Officer

    hace 4 semanas

    Madrid, Madrid, España Daiichi Sankyo A tiempo completo

    Job Title: Deputy Local Safety OfficerWe are seeking a highly skilled and experienced Deputy Local Safety Officer to join our team at Daiichi Sankyo. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our products and compliance with regulatory requirements.Key Responsibilities:Act as the Deputy of...

  • Deputy Local Safety Officer

    hace 4 semanas

    Madrid, Madrid, España Daiichi Sankyo A tiempo completo

    Job Title: Deputy Local Safety OfficerWe are seeking a highly skilled and experienced Deputy Local Safety Officer to join our team at Daiichi Sankyo. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our products and compliance with regulatory requirements.Key Responsibilities:Act as the Deputy of...

  • Global Safety Director

    hace 7 días

    Madrid, Madrid, España Teva Pharmaceuticals A tiempo completo

    Teva Pharmacovigilance - A Leader in Safety SolutionsAs a key member of our Medical Scientific Unit (MSU), the Director Global Pharmacovigilance will play a pivotal role in leading drug safety across our entire portfolio and product lifecycle. Collaborating with other Teva stakeholders, our MSU safety physicians and scientists will identify and define risks...

  • Medical Writer Specialist

    hace 3 semanas

    Madrid, Madrid, España Aixial Group A tiempo completo

    Medical Writer Role at Aixial GroupWe are seeking a skilled Medical Writer to join our team at Aixial Group. As a Medical Writer, you will be responsible for creating and updating clinical documents, including protocols, study reports, and regulatory submissions.Key Responsibilities:Gather information from technical contacts, including medical writers,...

  • Medical Writer

    hace 3 semanas

    Madrid, Madrid, España Aixial Group A tiempo completo

    Medical Writer (M/F)We are seeking a highly skilled Medical Writer to join our team at Aixial Group. As a key member of our clinical research team, you will be responsible for creating and updating clinical documents, including protocols, clinical study reports, and regulatory submissions.Key Responsibilities:Gather information from technical contacts,...

  • Risk Management Specialist

    hace 4 semanas

    Madrid, Madrid, España Innovative Medicines A tiempo completo

    About the RoleThe Risk Management Manager plays a critical role in identifying and categorizing risks that impact the Vigilance system and the broader PS&PV organization. This includes developing action plans for PS&PV leadership endorsement.Key ResponsibilitiesOversee the management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.Drive the...

  • Risk Management Specialist

    hace 4 semanas

    Madrid, Madrid, España Innovative Medicines A tiempo completo

    About the RoleThe Risk Management Manager plays a critical role in identifying and categorizing risks that impact the Vigilance system and the broader PS&PV organization. This includes developing action plans for PS&PV leadership endorsement.Key ResponsibilitiesOversee the management of Patient Safety Quality Issues and Quality Events in AQWA/1QEM.Drive the...

  • Drug Safety Team Leader

    hace 2 semanas

    Madrid, Madrid, España Insud Pharma A tiempo completo

    Job Summary:As Drug Safety Team Leader, you will be responsible for ensuring legal and regulatory compliance with pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).Key Responsibilities:• Coordinating part of the staff and activities related to the pharmacovigilance system, quality management system, safety from clinical trials,...

  • Risk and Health Safety Manager

    hace 1 mes

    Madrid, Madrid, España Rentokil Initial A tiempo completo

    Job Title: Risk and Health Safety ManagerWe are seeking a highly skilled Risk and Health Safety Manager to join our team at Rentokil Initial. As a key member of our organization, you will be responsible for ensuring that our health and safety management system is compliant with relevant laws and regulations, as well as our company's policies and...

  • Risk and Health Safety Manager

    hace 1 mes

    Madrid, Madrid, España Rentokil Initial A tiempo completo

    Job Title: Risk and Health Safety ManagerWe are seeking a highly skilled Risk and Health Safety Manager to join our team at Rentokil Initial. As a key member of our organization, you will be responsible for ensuring that our health and safety management system is compliant with relevant laws and regulations, as well as our company's policies and...

  • Senior Risk Management Strategist

    hace 4 semanas

    Madrid, Madrid, España Mygwork A tiempo completo

    About the RoleThis is a senior-level position within the Safety Management Team at Novartis, a leading pharmaceutical company. The successful candidate will be responsible for guiding the team on Good Pharmacovigilance Practices and other regulatory requirements for Safety Risk Management.Key ResponsibilitiesDevelop and implement a robust Risk Management...

  • Senior Risk Management Strategist

    hace 4 semanas

    Madrid, Madrid, España Mygwork A tiempo completo

    About the RoleThis is a senior-level position within the Safety Management Team at Novartis, a leading pharmaceutical company. The successful candidate will be responsible for guiding the team on Good Pharmacovigilance Practices and other regulatory requirements for Safety Risk Management.Key ResponsibilitiesDevelop and implement a robust Risk Management...

  • Senior Global Risk Management Plan Director

    hace 3 semanas

    Madrid, Madrid, España Federal Management System, Inc. A tiempo completo

    Job SummaryAs a Senior Global Risk Management Plan Manager at Federal Management System, Inc., you will guide the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management. You will provide strategic support to new submissions and...

  • Health and Safety Risk Manager

    hace 2 semanas

    Madrid, Madrid, España Fever España A tiempo completo

    About the RoleFever is seeking a Health and Safety Specialist to join its Health and Safety Team. As a key member of the team, you will be responsible for managing health and safety risks related to the company's own job positions and those associated with events promoted and/or arranged by Fever.Key ResponsibilitiesImplement health and safety management...

PV Benefit-Risk Safety Writer

hace 2 meses

Madrid, Madrid, España Baxter A tiempo completo

About Baxter

Baxter is a leading global healthcare company that has been a pioneer in the development of innovative medical products and technologies for over 70 years. Our mission is to save and sustain lives by bringing life-saving therapies to patients worldwide.

About the Role

We are seeking a highly skilled PV Benefit-Risk Safety Writer to join our team at Baxter. As a key member of our regulatory affairs team, you will play a critical role in ensuring the safety and compliance of our pharmaceutical products worldwide.

Key Responsibilities

  • Write standalone post-marketing aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), and associated reports, for regulatory submission.
  • As the main writer, you will be responsible for creating PV-RMPs using different templates provided by the company, while ensuring compliance with regional and local regulatory standards.
  • Perform quality control reviews of ASRs and PV-RMPs.
  • Facilitate cross-functional document review and approval by other contributors.
  • Ensure data issues are addressed and resolved prior to document sign-off.
  • Ensure all assigned ASRs/PV-RMPs are processed and submitted according to regulatory requirements and internal timelines.
  • Distribute ASRs/PV-RMPs for regulatory submission, to internal contacts and business partners per the established schedules and within regulatory requirements.
  • Regularly observe compliance, maintain compliance data, and prepare metrics.
  • Respond to queries/requests/assessment reports from regulatory authorities regarding ASRs and PV-RMPs.
  • Lead cross-functional project teams tasked with activities related to the implementation, tracking, and effectiveness evaluation of PV-RMP commitments.
  • Support the management in the establishment and maintenance of the ASR/PV-RMP schedules.
  • Support the management in audits and inspections.
  • Demonstrate solid understanding of the role of internal policies, conventions, and procedures in completing report assignments.
  • Support the creation, improvement and maintenance of standardized departmental procedures and processes.
  • Lead and participate on assigned project teams and committees.

Requirements

  • Equivalent experience in the pharmaceutical industry or a Bachelor's degree in a medical/scientific field; advanced degree and prior pharmaceutical industry experience is desired.
  • Prior experience authoring ASRs/PV-RMPs is desired
  • Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
  • Pharmacovigilance experience is a plus
  • Excellent scientific/clinical writing and editorial skills
  • Strong proficiency in both the primary language and English, with excellent verbal and written communication abilities.
  • Familiarity with medical terminology and scientific writing
  • Highly proficient computer skills and familiar with electronic publishing
  • Solid understanding of pharmacovigilance regulation requirements for ASRs preparation, PV-RMPs, and drug approval processes
  • Ability to perform detailed scientific analysis/evaluation of specialized information to support decision making
  • Editing proficiency including experience with document formatting (spelling, punctuation, capitalization, paragraph indentation, organization, style and conventions) for submission readiness
  • Demonstrate the ability to respond to and resolve inquiries and problems relating to assigned ASRs and PV-RMPs
  • Ability to independently manage long- and short-term project timelines and deliverables.
  • Experience in responding to queries/requests from regulatory authorities
  • Thrives in a collaborative team setting with diverse perspectives

What We Offer

  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance (Family Responsible Certificate efr)
  • Flexible benefits (childcare vouchers, employee discounts, etc.)
  • Commitment to growing and developing an inclusive and diverse workforce