Senior Manager, Pharmacovigilance

🔥 16 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 15%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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