Director, Pharmacovigilance, Telavant (Remote)

Telavant, a Roivant company, is a clinical-stage biotechnology company developing innovative therapies to treat inflammatory and fibrotic diseases.  Telavant’s first investigational product, RVT-3101, is a fully human monoclonal antibody targeting TL1A. We are developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach.

To learn more about our company and pipeline, visit us at https://www.telavanttx.com/.

About Roivant

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.

Position Summary: 

The Director, Pharmacovigilance (PV) will support the evaluation/implementation of a core PV system, identification/management of “preferred” PV vendors for outsourced activities, and SOP library creation in collaboration with Central Roivant PV team. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution. This person will provide strategic safety data analyses and input to support clinical development activities, ensuring compliance for all pharmacovigilance regulatory reviews and submissions. 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 supporting PV systems, CRO relationship/process improvement, outsourced activities and deliverables related to PV
• Author and review drug safety sections of protocols, ICFs, IBs, CSRs and other documents including safety management plans, aggregate safety reports [e.g., DSURs, Annual Reports etc.], Safety Surveillance Plans and IND/BLA packages.
• 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
• Perform ongoing safety surveillance (including signal detection/evaluation) of 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
• Liaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents. Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
• 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
• 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, PhD, 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

Telavant 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. 

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or Roivant Sciences, affiliated employees, or any of our subsidiary companies.