FSP Associate Manager, Safety Data & Systems

🕒 il y a 2 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Lead deliverables for Global Patient Safety safety data management and safety system maintenance activities • Provide high-quality data outputs for safety signal management, risk management, and safety evidence generation • Manage and monitor applicable GPS mailboxes, including unblinded data • Serve as the key technical resource for configuration, maintenance, and administration of the Oracle Argus Safety system • Support day-to-day Argus Safety operation and troubleshooting for reliable and compliant drug safety case processing • Assist with system validation, testing, and deployment of Argus updates, workflows, and business rules • Generate, validate, and customize safety reports and analytics using Argus reporting tools and business intelligence platforms • Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with FDA, EMA, PMDA, and ICH standards • Participate in change management to improve Argus workflows and system integrations • Contribute to audit readiness, system inspections, validation reports, and compliance documentation • Collaborate with internal systems teams, BIS, and safety vendors on safety database configuration issues • Generate and quality-control aggregate reports and line listings • Develop procedural documents, including Safety Management Plans, SOPs, work instructions, job aids, forms, and templates • Collaborate with client functions on pharmacovigilance technical setup and operations • Keep current on regulatory and pharmacovigilance technology guidelines and share updates with GPS and clients • Participate in safety data management training • Review processes and tools proactively and suggest efficiency improvements • Complete additional tasks and projects assigned by the line manager or Head of GPS Operations

🎯 Exigences

• At least Bachelor's degree (or country equivalent) in life sciences, Information Technology, or another relevant field required • Minimum of 7 years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance • At least 3 years of proven experience with safety database systems such as Argus or ArisG, including workflow management • Solid knowledge of global EU, US, and Asia-Pacific pharmacovigilance requirements and practices • Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents, including Europe, US, and Japan • Adequate computer skills in current office applications • Proficiency with Excel required; SQL experience is a plus • Proficiency in safety database systems, such as Argus, and knowledge of E2B gateways and safety signal detection tools • Proficiency with electronic Safety/PV systems for data visualization, analysis, and dashboards • Robust understanding of end-to-end clinical and post-marketing safety event collection and reporting, workflow-based case processing, and MedDRA dictionary • Solid understanding of development and submission of aggregate safety reports, such as DSUR and PSUR • Solid understanding of quality management processes, metrics, and KPIs • Fluent written and spoken English required • Ability to work independently with minimal oversight and prioritize effectively • Ability to complete multiple complex deliverables within tight timelines • Ability to function effectively in a team environment • Equivalent and adequate combination of education and experience or proven practical expertise in all required skills

🏖️ Avantages

• Fully remote work arrangement • Standard Monday–Friday work schedule