Senior Manager, Pharmacovigilance

🕒 il y a 5 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 20%

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.

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Pulmovant

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Pulmovant est une entreprise dédiée à transformer la vie des patients atteints de maladies pulmonaires en développant des thérapies innovantes. Leur produit phare, le mosliciguat, vise à offrir un traitement inhalé quotidien pour l'hypertension pulmonaire, se distinguant par son mécanisme novateur d'activation de la sGC. Avec un objectif unique de répondre aux besoins spécifiques des patients souffrant de pathologies pulmonaires, Pulmovant s'engage dans des essais cliniques approfondis pour faire progresser ses options de traitement pionnières.

Description

• Serve as a pharmacovigilance subject matter expert for ongoing and future clinical trials, including Phase 1 studies and the Phase 3 PHrontier study • Oversee end-to-end case management for serious adverse events, including intake, triage, medical review coordination, regulatory reporting, and ICSR quality control • Maintain safety mailboxes • Monitor expedited reporting timelines and case quality metrics • Reconcile safety data across clinical operations, CROs, and safety vendors • Support event adjudication, Safety Review Committee activities, and IDMCs • Review and author safety documents, including Safety Management Plans, Investigator Brochures, protocols, informed consents, and Letters of Authorization • Support quarterly Safety Review Committee activities and maintain signal assessment logs • Support signal detection, validation, evaluation, and escalation • Contribute to risk management plans and safety monitoring plans • Review aggregate safety reports, including DSURs, six-month line listings, and ad hoc safety summaries • Maintain reporting calendars and data-lock timelines • Track safety-related regulatory commitments and support responses to health authority queries • Oversee PV vendor and CRO relationships, including Oracle Argus Safety, case processing, and literature surveillance • Manage vendor governance meetings, KPIs, quality metrics, issue escalation, and CAPA follow-up • Support PV vendor qualification and onboarding, including PVAs • Ensure compliance with ICH-GCP, FDA, EMA, global regulations, and GVP guidance • Author, review, and maintain PV SOPs, work instructions, and controlled documents • Participate in audit and inspection readiness activities • Perform quarterly QC of the electronic Trial Master File • Represent Pharmacovigilance in cross-functional safety management and CRO meetings • Provide PV training and guidance to internal stakeholders and investigator sites • Mentor junior safety staff and contribute to strategic PV planning

🎯 Exigences

• Bachelor's degree in life sciences, nursing, pharmacy, or related field required • Minimum of approximately 7+ years of pharmacovigilance/drug safety experience in the biotechnology or pharmaceutical industry • Demonstrated experience with clinical trial safety surveillance and case management • Working knowledge of global PV regulations and guidance, including FDA, EMA, ICH E2 series, and GVP modules • Experience authoring or contributing to DSURs, PSURs/PBRERs, and risk management plans • Familiarity with safety database systems such as Oracle Argus Safety • Strong analytical, medical/scientific writing, and cross-functional communication skills • Ability to manage multiple priorities independently in a fast-paced, resource-lean biotech environment • Post-marketing pharmacovigilance and/or launch-readiness experience • Experience supporting health authority inspections or internal/external audits • Experience negotiating or managing Safety Data Exchange Agreements (SDEAs) and pharmacovigilance agreements (PVAs) with development or commercial partners

🏖️ Avantages

• Equal employment opportunities and protection from discrimination and harassment • Opportunity to work in a fast-paced, growing biotechnology environment • Mentorship and guidance opportunities as part of the PV function