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    Director Of Pharmacovigilance And Drug Safety Operations (Remote)

    Roivant
    10+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director of PV/Drug Safety Operations
    Location: Remote / US-based
    Company: Roivant Sciences

    About Roivant:

    Roivant’s mission is to reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates. Since its founding in 2014, Roivant has achieved several critical milestones, including the establishment of over 20 portfolio companies (Vants), 5 successful IPOs, 10 consecutive positive Phase 3 trials, 6 FDA approvals, and >$10 billion in global pharma partnerships. Roivant is also the commercial partner for VTAMA®, a treatment for plaque psoriasis, and is expanding its capabilities in drug discovery and development.

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

    Position Summary:

    Roivant Sciences is seeking a Director of PV/Drug Safety Operations to provide strategic and tactical oversight for drug safety and pharmacovigilance (PV) operations. This role involves working closely with the drug safety team, regulatory affairs, and cross-functional teams to ensure the safety and regulatory requirements for Roivant’s clinical development programs are met. The Director will oversee safety systems, processes, and databases, and be the subject matter expert on drug safety throughout the lifecycle of novel drug development. The ideal candidate will have extensive experience in drug development from early Phase 1 to late Phase 3 clinical studies, and expertise in supporting global programs in a collaborative team environment.

    Key Responsibilities:

    • Safety Systems & Infrastructure: Develop, implement, and manage Roivant’s drug safety/PV infrastructure, ensuring safety processes, SOPs, and safety database systems are effective and compliant.
    • Vendor & Partner Management: Work closely with external vendors for safety case processing, system management, and regulatory reporting. Develop and manage pharmacovigilance agreements with external partners.
    • Clinical Safety Oversight: Oversee safety assessments for clinical studies, from study design to individual safety case reports. Ensure that all clinical study-specific safety data is accurately managed.
    • Cross-functional Collaboration: Collaborate with Roivant’s drug safety teams and Vants to ensure safety responsibilities are fully addressed. Work closely with regulatory affairs teams to meet drug safety reporting requirements.
    • In-Licensing & Diligence: Lead drug safety assessments for in-licensing due diligence, and serve as the subject matter expert on drug safety during program and diligence teams.
    • Regulatory Landscape: Stay up-to-date on evolving global regulatory requirements related to drug safety and pharmacovigilance, ensuring Roivant’s compliance with safety regulations.

    Qualifications & Requirements:

    • Education: RN, MS, MPH, PharmD, or equivalent degree.
    • Experience: Minimum of 15 years in drug development within the pharmaceutical industry, with expertise in both early Phase 1 and late Phase 3 clinical studies.
    • Global Clinical Experience: Extensive experience managing global clinical studies and meeting global safety reporting requirements.
    • PV Expertise: Strong understanding of pharmacovigilance processes, quality requirements, and regulatory standards.
    • Collaboration & Communication: Proven ability to work collaboratively with internal teams, external vendors, contractors, and strategic partners. Excellent verbal and written communication skills.
    • System Expertise: Experience with ArisGlobal LSMV and Veeva Vault systems is preferred.
    • Leadership: Must be a highly motivated, decisive, and results-oriented individual, able to lead multiple projects independently while fostering teamwork and collaboration.

    Why Roivant:

    At Roivant, we are building the next generation of biopharma by applying technology and a novel approach to drug discovery. Our mission to reduce the time, cost, and risk of bringing life-changing medicines to market is at the heart of everything we do. We offer a dynamic, fast-paced environment where talented individuals can thrive, make an impact, and contribute to improving patients' lives.

    How to Apply:

    To apply or learn more, visit our careers page:
    Roivant Careers

    Roivant Sciences is an equal opportunity employer and is committed to fostering a diverse and inclusive workforce.

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