Senior Manager, Pharmacovigilance

The Senior Manager, Pharmacovigilance will support the ongoing safety surveillance and risk management activities for Pulmovant’s pipeline of respiratory therapeutics. Reporting to the Director, Pharmacovigilance, this role requires deep expertise in drug safety operations, hands-on experience with Argus Safety, and a proven track record managing pharmacovigilance (PV) vendors and Contract Research Organizations (CRO) relationships.

Key Duties and Responsibilities:

• Serve as a pharmacovigilance subject matter expert supporting Pulmovant’s multiple ongoing and future clinical trials, including fast-paced Phase 1 studies and the Phase 3 PHrontier study of mosliciguat in PH-ILD.
• Oversee end-to-end case management for serious adverse events (SAEs), ensuring accurate intake, triage, medical review coordination, and timely regulatory reporting. Quality Control (QC) of all Individual Case Safety Reports (ICSRs).
• Maintain the safety mailboxes and monitor expedited reporting timelines and case quality metrics.
• Support event adjudication, Safety Review Committee (SRC) activities, and Independent Data Monitoring Committees (IDMCs).
• Contribute to document review and authoring for the Safety Management Plan, Investigators Brochure, Protocols, Informed Consents, and Letters of Authorization.
• Assist with the quarterly Safety Review Committee, integrating cumulative safety data across all studies, and maintaining a documented signal assessment log with disposition rationale.
• Support signal detection and evaluation activities, including periodic review of aggregate safety data, signal validation, and escalation per Pulmovant’s signal management plan.
• Contribute to the development and maintenance of risk management plans (RMPs) and safety monitoring plans in partnership with Regulatory Affairs and Clinical Development.
• Support safety-related content for protocols, investigator brochures, informed consent forms, and clinical study reports.
• Review aggregate safety reports, including Development Safety Update Reports (DSURs), 6-month line listings, and ad hoc safety summaries.
• Maintain reporting calendars and data-lock timelines to ensure on-time delivery of safety deliverables to health authorities.
• Track safety-related regulatory commitments and support responses to health authority safety queries.
• Oversee PV vendor and CRO relationships, including safety database management (e.g., Oracle Argus Safety), case processing, and literature surveillance.
• Manage vendor governance meetings, Key Performance Indicators (KPIs), quality metrics, and issue escalation/Corrective and Preventive Action (CAPA) follow-up.
• Support qualification and onboarding of PV vendors, including pharmacovigilance agreements (PVAs) with development or commercial partners.
• Ensure PV activities comply with ICH-GCP, FDA, EMA, and other applicable global regulations and Good Pharmacovigilance Practice (GVP) guidance.
• Author, review, and maintain PV Standard Operating Procedures (SOPs), work instructions, and controlled documents.
• Participate in audit and inspection readiness activities, including mock inspections and responses to health authority inspections.
• Quarterly Quality Control (QC) of the electronic Trial Master File (eTMF) ensuring all appropriate documents are included.
• Represent Pharmacovigilance on cross-functional safety management teams and CRO meetings.
• Provide PV training and guidance to internal stakeholders and investigator sites, as needed.
• Mentor and provide guidance to junior safety staff and contribute to strategic planning for the PV function as Pulmovant scales toward potential commercialization.