Senior Manager, Pharmacovigilance, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. 

Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Position: Senior Manager, Pharmacovigilance

Summary: 

The Senior Manager, Pharmacovigilance, will support the ongoing safety surveillance and risk management activities for our pipeline of respiratory therapeutics. In this role, you will oversee case processing, signal detection, and aggregate safety reporting (DSURs) while ensuring compliance with global pharmacovigilance regulations and ICH guidelines. You will serve as a key safety partner to clinical development, regulatory affairs, and medical teams, contributing to risk management plans, safety data review committees, and health authority interactions. Reporting to the Director, Pharmacovigilance, the ideal candidate brings deep expertise in drug safety operations, hands-on experience with Argus Safety, and a proven track record managing PV vendors and CRO relationships, along with strong analytical and leadership skills to operate effectively in a fast-paced, growing biotech environment.

KeyDuties 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 ICSRs.
• Maintain the safety mailboxes.
• Monitor expedited reporting timelines and case quality metrics; ensure reconciliation of safety data across clinical operations, CROs, and safety vendors.
• Support event adjudication, Safety Review Committee (SRC) activities and IDMCs.
• Contributing to document review and authoring (as needed) for the Safety Management Plan, Investigators Brochure, Protocols, Informed Consents and Letters of Authorizations.
• Assist with the quarterly Safety Review Committee integrating cumulative safety data across all studies, 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, KPIs, quality metrics, and issue escalation/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 GVP guidance.
• Author, review, and maintain PV 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 team 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.

Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or related field required; advanced degree (PharmD, PhD, MSN, or MPH) preferred.
• 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 (FDA, EMA, ICH E2 series, 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.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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