Senior Physician Safety Writer H/F
il y a 2 semaines
Vantive: A New Era in Kidney Care
Baxter is embarking on a transformative journey to separate its ~$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, providing best-in-class care to those we serve.
At Vantive, you will become part of a community of individuals driven to improve patients' lives worldwide. Our team is focused, courageous, and committed to excellence. We are seeking a Senior Physician Safety Writer (PSW) to join our ranks.
Key Responsibilities
- Prepare, review, and distribute aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for submission to regulatory agencies worldwide.
- Ensure compliance with regional and local regulatory requirements.
- Perform quality control reviews of ASRs and PV-RMPs.
- Facilitate cross-functional document review and approval.
- Manage project timelines and deliverables.
Requirements
- Medical degree with a minimum of 2 years pharmacovigilance industry experience.
- Prior experience authoring ASRs/PV-RMPs and providing medical knowledge for safety signal work-ups and benefit-risk assessments is desired.
- Excellent scientific/clinical writing and editorial skills.
- Outstanding verbal and written communication skills in English.
- Highly proficient computer skills and familiar with electronic publishing.
What You'll Bring
- Medical expertise and knowledge of pharmacovigilance regulation requirements.
- Ability to perform detailed scientific analysis/evaluation of specialized information.
- Strong analytical and problem-solving skills.
- Ability to work effectively in a global team environment.
About Vantive
Vantive is a new company built on our legacy in kidney care. We are committed to providing best-in-class care to those we serve. Our team is driven to improve patients' lives worldwide.
-
Senior Physician Safety Writer
il y a 3 semaines
Guyancourt, Île-de-France Baxter Temps pleinSenior Physician Safety WriterBaxter is seeking a highly skilled Senior Physician Safety Writer to join our team. As a key member of our pharmacovigilance team, you will be responsible for preparing and submitting aggregate safety reports and pharmacovigilance risk management plans to regulatory agencies worldwide.Key Responsibilities:Prepare and submit...
-
Senior Physician Safety Writer
il y a 4 semaines
Guyancourt, Île-de-France Baxter Temps pleinSenior Physician Safety WriterBaxter is seeking a highly skilled Senior Physician Safety Writer to join our team. As a key member of our pharmacovigilance team, you will be responsible for preparing and submitting aggregate safety reports and pharmacovigilance risk management plans to regulatory agencies worldwide.Key Responsibilities:Prepare and submit...
-
Senior Physician Safety Writer
il y a 4 semaines
Guyancourt, Île-de-France Baxter Temps pleinSenior Physician Safety WriterBaxter is seeking a highly skilled Senior Physician Safety Writer to join our team. As a key member of our pharmacovigilance team, you will be responsible for preparing and submitting aggregate safety reports and pharmacovigilance risk management plans to regulatory agencies worldwide.Key Responsibilities:Prepare and submit...
-
Senior Physician Safety Writer
il y a 4 semaines
Guyancourt, Île-de-France Baxter Temps pleinSenior Physician Safety WriterBaxter is seeking a highly skilled Senior Physician Safety Writer to join our team. As a key member of our pharmacovigilance team, you will be responsible for preparing, reviewing, and submitting aggregate safety reports and pharmacovigilance risk management plans to regulatory agencies worldwide.Key Responsibilities:Prepare and...
-
Senior Physician Safety Writer
il y a 4 semaines
Guyancourt, Île-de-France Baxter Temps pleinSenior Physician Safety WriterBaxter is seeking a highly skilled Senior Physician Safety Writer to join our team. As a key member of our pharmacovigilance team, you will be responsible for preparing, reviewing, and submitting aggregate safety reports and pharmacovigilance risk management plans to regulatory agencies worldwide.Key Responsibilities:Prepare and...
-
Senior Physician Safety Writer H/F
il y a 2 semaines
Guyancourt, Île-de-France Baxter Temps pleinTransforming 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.Senior Physician Safety Writer RoleWe are...
-
Senior Physician Safety Specialist
il y a 3 jours
Guyancourt, Île-de-France Baxter Temps pleinVantive: Transforming Kidney CareBaxter is embarking on a transformative journey to establish Vantive as a standalone company, building on our legacy in acute therapies and home and in-center dialysis. This move will enable Vantive to provide best-in-class care to those we serve, while also offering meaningful work to those who join us.At Vantive, we are a...
-
Senior Physician Safety Writer H/F
il y a 1 semaine
Guyancourt, Île-de-France Baxter Temps pleinVantive: A New Company Built On Our LegacyBaxter 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...
-
Lead Safety Medical Writer
Il y a 2 mois
Guyancourt, Île-de-France Baxter Temps pleinJoin Baxter in a Pioneering RoleBaxter is seeking a Lead Safety Medical Writer to enhance our commitment to advancing kidney care and organ support. In this pivotal role, you will be tasked with the preparation, quality assurance, and dissemination of aggregate safety reports (ASRs) and pharmacovigilance risk management plans (PV-RMPs) for global regulatory...
-
Ingénieur de Sûreté de Fonctionnement H/F
il y a 6 jours
Guyancourt, Île-de-France SERMA SAFETY & SECURITY Temps pleinMissionL'objectif de ce stage est de capitaliser les études de sûreté de fonctionnement au sein de la BU de SERMA SAFETY & SECURITY. Nous recherchons un stagiaire pour identifier les méthodologies et livrables à capitaliser, interagir avec les chefs de projet et ingénieurs, définir la structure de la plateforme de capitalisation et réaliser les...
-
Ingénieur Sûreté de Fonctionnement H/F
il y a 6 jours
Guyancourt, Île-de-France SERMA SAFETY & SECURITY Temps pleinProjet de recherche en sûreté de fonctionnement des logiciels critiquesSERMA SAFETY & SECURITY recherche un stagiaire pour travailler sur un projet de recherche dans le domaine de la sûreté de fonctionnement des logiciels critiques et l'utilisation de l'IA générative.L'objectif principal du projet est de déterminer dans quelle mesure une IA...
-
Ingénieur senior en sécurité aérienne
il y a 4 semaines
Guyancourt, Île-de-France Egis Avia Temps pleinMissionVous rejoindrez les équipes de sécurité de l'entité Aviation d'Egis, où vous contribuerez aux activités d'études de sécurité dans le domaine de la gestion du trafic aérien (ATM) en France ou en Europe.Compétences requisesMaîtrise des méthodes, techniques et outils applicables pour la réalisation d'études de sécuritéConnaissance des...
-
Technicien Electricite CFA H/F
il y a 1 mois
Guyancourt, Île-de-France EQUANS Temps pleinJob DescriptionAs a Technicien Electricite CFA H/F at Equans France, you will be part of a dynamic team responsible for delivering high-quality electrical services to clients in the tertiary sector. Your primary role will be to perform electrical work on various projects, including renovation and construction of buildings, ensuring compliance with safety...
-
Pâtissier F/H
il y a 4 semaines
Guyancourt, Île-de-France Elior Group Temps pleinJoin Our Team as a Pâtissier F/HWe are seeking a skilled and passionate Pâtissier F/H to join our team at Elior Group. As a Pâtissier F/H, you will be responsible for creating delicious pastries and desserts that exceed our customers' expectations.About the RoleAs a Pâtissier F/H, you will work in a fast-paced kitchen environment, preparing and...
-
Ingénieur senior en sécurité aérienne
il y a 1 mois
Guyancourt, Île-de-France Egis Avia Temps pleinMissionVous rejoindrez l'équipe sécurité de l'entité Aviation d'Egis, où vous contribuerez aux activités d'études de sécurité dans le domaine de la gestion du trafic aérien (ATM), en France ou en Europe.Compétences requisesMaîtrise des méthodes, techniques et outils applicables pour la réalisation d'études de sécurité idéalement dans le...
-
Clinical Specialist
il y a 4 semaines
Guyancourt, Île-de-France Edwards Lifesciences Temps pleinJob Title: Clinical Specialist - Critical CareAt Edwards Lifesciences, we are seeking a highly skilled Clinical Specialist to join our team in Paris, France. As a Clinical Specialist, you will play a key role in supporting our Account Managers and Sales Manager in driving sales and profit objectives for our region and product portfolio.Key...
-
Ingénieur senior en sécurité aérienne
il y a 1 mois
Guyancourt, Île-de-France Egis Avia Temps pleinMissionVous rejoindrez les équipes de sécurité de l'entité Aviation d'Egis, où vous contribuerez aux activités d'études de sécurité dans le domaine de la gestion du trafic aérien (ATM) en France ou en Europe.Compétences requisesMaîtrise des méthodes, techniques et outils applicables pour la réalisation d'études de sécurité idéalement dans...
-
Chef de Projets IT Senior H/F
il y a 2 semaines
Guyancourt, Île-de-France Crédit Agricole CIB Temps pleinDescription du posteType de métierLes métiers de l'informatique et des opérations sont à la pointe de l'innovation technologique. Les équipes accompagnent les activités et projets de développement des différents métiers de la Banque de Financements et d'Investissement dans un environnement international.Intitulé du posteChef de Projets IT Senior...
-
Dietéticien H/F
il y a 1 mois
Guyancourt, Île-de-France Sodexo Temps pleinTitre du Poste Nous recherchons un Dietéticien H/F pour rejoindre notre équipe.Présentation du Poste Le poste de Dietéticien H/F consiste à élaborer des menus avant commission, à apporter des modifications dans notre outil SOL, à participer aux commissions de menus, à assurer des missions d'éducation nutritionnelle auprès d'enfants,...
-
Clinical Specialist
il y a 3 semaines
Guyancourt, Île-de-France Edwards Lifesciences Temps pleinJob Title: Clinical Specialist - Critical CareAt Edwards Lifesciences, we are seeking a highly skilled Clinical Specialist to join our team in Paris, France. As a Clinical Specialist, you will play a key role in supporting our Account Managers and Sales Manager in driving sales and profit objectives for our region and product portfolio.Key...