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.
