Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.

To learn more about our story and company culture, please visit us at https://roivant.com/

Position Summary:

The Senior Manager, Drug Safety/Pharmacovigilance (DSPV) is an operational role reporting to the Director, DSPV in the Drug Safety Operations (DSO) group within the Regulatory Affairs & Drug Safety department at Roivant. DSO supports the safety needs of clinical-phase Roivant subsidiaries (Vants) from the time a development program is in-licensed and a new Vant is created until the subsidiary is equipped to cover its own DSPV needs. The Senior Manager, DSPV must be an effective collaborator, both cross-functionally within the Roivant family of businesses and with external safety service providers. 

The Senior Manager, DSPV will participate in the continued development and maintenance of the core PV system at Roivant, including helping expand the library of safety-related SOPs/Work Instructions, identifying and managing preferred PV vendors for outsourced activities (eg, case processing, DSUR preparation), serving as a Business Administrator for the safety database system, supporting the activities of the Product Safety Management Committee, and working toward continuous safety inspection readiness. This person will also represent DSPV on assigned clinical study teams and participate in the development of various business, regulatory, and clinical documents in his/her capacity as DSPV Subject Matter Expert. The Senior Manager, DSPV may also be involved in the more scientific and/or clinical aspects of drug safety practice, time permitting and as assigned by the Director, DSPV.

Key Responsibilities:

• 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)

Skills, Qualifications, and Requirements

• 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

Roivant Sciences 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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