Director of Pharmacovigilance and Drug Safety Operations (Remote)
: Job Details :

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; 10 consecutive positive phase 3 trials; 6 FDA approvals; >10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic areas; successful commercial launch of 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 Position Summary:The Director of PV/Drug Safety Operations will provide the strategic and tactical oversight for Roivant's drug safety operations and handle program level drug safety/PV activities. This position will work closely with the existing drug safety team and the head of regulatory affairs and drug safety to insure all aspects of drug safety operational requirements for novel drug clinical development are managed. The role will require direct hands-on management of safety systems oversight, safety infrastructure implementation, safety processes, program level drug safety assessment and have a strong understanding of drug safety science. A successful candidate must have significant experience in drug development encompassing early phase 1 to late phase 3 clinical studies and have worked in supporting global programs within a highly cross-functional team structure. Responsibilities:Works with external vendors on safety case processing and systems managementDevelops and implements when necessary drug safety/PV infrastructure and systemsOversees and manages Roivant's safety database systemOversees safety processes and SOPsWorks with existing drug safety team at Roivant and at subsidiary Vants to insure all drug safety responsibilities are appropriately handledWorks closely with regulatory affairs at Roivant and/or at the subsidiary Vants to insure all drug safety regulatory reporting requirements are metResponsible for developing and managing any pharmacovigilance agreements with external partnersBe able to assess clinical study specific safety, whether it is at the study design standpoint or at the level of a specific safety case reportHandle in-licensing due diligence from a drug safety/PV standpointFunctions as the drug safety/pharmacovigilance subject matter expert on program and diligence teamsKeeps up to date on changing regulatory landscape as it applies to drug safety and pharmacovigilanceSkills, Qualifications and Requirements:RN, MS, MPH, PharmD or equivalent degreeMinimum 15 years of drug development experience in the pharmaceutical industryMust have experience in phase 1 early stage programs through phase 3 late stage programsMust have experience in global clinical studies and reporting requirementsStrong understanding of PV processes and quality requirementsHighly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, including external vendors, contractors and strategic partnersExcellent verbal and written skills, allows for an open and effective dialogue throughout the company.Experience with ArisGlobal LSMV and Veeva Vault systems is preferredMust be able to command respect from peers and capable of highly independent work as well as being a team player and role model.Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.Requires proven ability to manage multiple projects.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.We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!