Senior Manager
Drug Safety/Pharmacovigilance, Remote
Confirmed live in the last 24 hours
Roivant Sciences

201-500 employees

Develops medicines and technologies for underfunded diseases
Company Overview
Roivant Sciences stands out as a unique player in the biotech and healthcare technology industry with its nimble, entrepreneurial approach to developing medicines and technologies. The company strategically acquires underutilized drugs from larger pharmaceutical companies, focusing on therapies for diseases that are often overlooked due to disproportionate R&D investment. With a proven track record, including the successful $3 billion sale of five of its subsidiaries to Sumitomo Pharma, Roivant demonstrates its ability to turn overlooked opportunities into profitable ventures, while also addressing critical societal medical needs.
Consumer Goods
Data & Analytics

Company Stage


Total Funding





New York, New York

Growth & Insights

6 month growth


1 year growth


2 year growth

Remote in USA
Experience Level
Desired Skills
Data Analysis
Legal & Compliance
  • Life sciences degree and/or background in a clinical field (eg, RN, PharmD) required
  • Minimum 6 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry, including processing cases, preparing aggregate safety reports, and ensuring the quality of safety activities/deliverables
  • Minimum 2 years of experience directly providing oversight of safety case processing, including negotiating Safety Management Plans
  • Experience representing the safety function on clinical study teams, including reviewing safety-related content in clinical documents (eg, protocols, ICFs, IBs, CSRs)
  • Experience writing/maintaining procedural documents on safety topics
  • Recent experience working in ArisGlobal's LifeSphere MultiVigilance and Reporting and Analytics tool preferred
  • Familiarity with Veeva's EDC and quality document management systems is preferred
  • Experience supporting safety inspections and/or inspection readiness activities is preferred
  • Strong verbal communication and interpersonal skills
  • Proficiency in technical and business writing
  • Proficiency in planning, monitoring and operational problem solving
  • Flexibility to work in a fast-paced environment, shifting on and off projects as needed
  • Ability to manage multiple and diverse issues
  • Strong organization, analytical, documentation, and time management skills
  • Support the Director, PV in development/maintenance of all aspects of the company's PV system, coordination/oversight of outsourced PV activities/deliverables, CRO relationship/process improvement, and safety inspection preparedness activities
  • Represent safety on assigned clinical study teams and provide review, writing, and quality control support for drug safety sections of protocols, ICFs, IBs, and CSRs
  • Collaborate with Biometrics and Data Management in the review of EDC system SAE forms/notifications and safety tables, figures, and listings for assigned clinical studies
  • Collaborate with Regulatory Affairs, Clinical, and Quality to ensure the appropriate reporting of DSPV information and provide input into mitigation measures to achieve the expected risk management outcomes
  • Contribute to the development of documents governing safety activities, such as Pharmacovigilance Agreements and Safety Management Plans for assigned programs
  • Author, coordinate, oversee development, and/or provide quality control for aggregate safety reports (eg, DSURs) for assigned programs
  • Help develop and maintain Drug Safety & PV Standard Operating Procedures, Work Instructions, and Forms
  • Conduct adverse event, literature, and other safety-relevant data analysis for the purpose of signal detection, and document signal management activities under the guidance of the Director, PV
  • Help prepare agendas, minutes, and other meeting materials for Product Safety Management Committee meetings
  • With the Director, PV, serve as Business Administrator for Roivant's cloud-hosted ArisGlobal LifeSphere MultiVigilance safety database system and the associated
  • LifeSphere Reporting and Analytics tool (eg, coordinate/verify training, manage user account requests, review system version notes before upgrades for business impact)