Director Drug Safety/Pharmacovigilance (PV)

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:  launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019.  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 first large tech-enabled pharmaceutical company.

As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio. 

Position Summary: 

The Director, Drug Safety/Pharmacovigilance (PV) will lead and oversee the evaluation/implementation of a core PV system, identification/management of “preferred” PV vendors for outsourced activities, and SOP library creation. The role will also entail being a thought partner for Vant PV leads on the operation and the execution of safety deliverables at the Vant companies. This person will provide strategic safety data analyses and input to support clinical development activities, ensuring compliance for all pharmacovigilance regulatory reviews and submissions, and determining and evaluating all safety signals in conjunction with the clinical team during Vant creation. S/he must effectively collaborate effectively cross-functionally within the organization as well as with external safety service providers and regulatory authorities.  

Responsibilities

• Responsible and accountable for developing PV systems, CRO relationship/process improvement, outsourced activities and deliverables related to PV
• Provide strong medical writing/review support for drug safety sections of protocols, ICFs, IBs, CSRs and other documents including safety management plans and aggregate safety reports [e.g., DSURs, Annual Reports etc.]
• Develop Drug Safety Standard Operating Procedures
• Conduct adverse event, literature, and other safety-relevant data analysis for the purpose of signal detection
• Evaluate need and lead implementation, if applicable, of a safety database including informing on configuration and validation
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Assist in the formation of an appropriate safety governance structure processes in order to provide CRO oversight and be a Vant thought partner in the identification, assessment and communication of potential safety signals
• Collaborate with Regulatory Affairs, Clinical and Quality to ensure appropriate reporting of PV and drug safety information and help inform risk mitigation measures that achieve the expected risk management outcomes
• Monitor industry best practices and changes in global safety regulations and guidelines
• Contribute to preparation and quality control activities for key safety documents
• Collaborate with a team of professionals who provide medical monitoring support for ongoing clinical trials on a global basis
• Provide ongoing updates as necessary on business development/licensing activities pertaining to risk-benefit profile of our products and competitors’ products in clinical trials
• Ensure departmental budgets and schedules meet corporate requirements
• Coordinate responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans
• Provide input to potential in-licensing opportunities and pharmacovigilance agreements with partners
  

Skills, Qualifications, and Requirements

• Advanced degree (MD, DO, RN or PharmD preferred)
• Minimum 8+ years of Pharmacovigilance/drug safety/drug development experience in the biopharmaceutical industry
• Proficiency in strategizing, planning, monitoring and problem solving
• Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organization
• Flexibility to work in a fast-paced environment
• Ability to manage multiple and diverse issues
• Strong facilitation, organizational, analytical 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.