Pharmacovigilance Manager

Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
Icosavax seeks an experienced Pharmacovigilance Manager to lead and manage safety oversight for clinical studies in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines. She/he will manage external partners (eg CROs, consultants, Safety Monitoring Committee) parties while adhering to budget, scope, and timeline requirements and applicable regulations.
Partner with the Pharmacovigilance physicians/Medical Monitors to provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, management of potential safety issues, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries/IRB/EC requests on product safety issues for assigned product(s) during all phases of the product life-cycle
Provide oversight for external safety reporting to health authorities, investigators, and partners as required
Effective communication skills for close collaboration with colleagues from other functions including but not limited to Clinical Development, Biostatistics, Regulatory Affairs, and Medical Affairs
Review safety sections and provide safety content for study protocols and ICFs, safety management and expedited reporting plans, clinical study reports with associated tables, listings and figures for safety data, and other study related documents
Support updates to Investigator Brochure, Company Core Safety Information, and other Reference Safety Information
Review and prepare adverse event data, literature, and other safety-relevant data for the purpose of signal analyses
Lead and complete regulatory submission of required aggregate study reports such as annual Development Safety Update Reports for ICVX candidate vaccines to support regulatory compliance in the study region
Contribute to safety contents for aggregate reports and risk management plans
Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
6+ years pharmacovigilance experience including safety signal management, clinical trial support and aggregate report
Expertise in Argus Safety Database (or equivalent), MedDRA, SharePoint, Microsoft Office, and Excel
Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Excellent time management skills
Independently motivated, detail oriented and strong problem-solving ability
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
Excellent written and verbal communication skills with the ability to interact across multiple functions
Knowledge in global pharmacovigilance regulations
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Location: Remote USA
Must be eligible to work in the USA
To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law.
The salary range for this position is $130,000 – 150,000 per year; the base salary will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.

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