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Director, Drug Safety & Pharmacovigilance- Safety Surveillan

Company: Neurocrine Biosciences
Location: San Diego
Posted on: April 9, 2021

Job Description:

Director, Drug Safety & Pharmacovigilance- Safety Surveillance Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives. What We Do: Neurocrine Biosciences --is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in-- San Diego ,-- Neurocrine Biosciences --specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie) About the Role:Provide strategic leadership and guidance on safety surveillance activities (eg, signal management, aggregate safety reports, etc.) and manages risk strategies for all Neurocrine products (all phases of development and post approval) across all programs. Collaborate with DSPV team and cross functional team on safety surveillance activities related to analysis of safety data, identifying, detecting and investigating safety signals, and evaluating and proactively managing safety risks. Serve as the Safety Scientist Lead for assigned compounds in clinical development and/or post approval. May also work with the DSPV Operations group to perform case processing activities as needed by the department._Your Contributions (include, but are not limited to):

  • Provide strategic leadership and guidance on safety surveillance activities (eg, signal management, aggregate safety reports, etc.) across all NBI programs.
  • In collaboration with the DSPV Medical Director, oversees the implementation and coordination of the safety surveillance process.
  • Performs safety signal management activities to detect, analyze, and investigate safety signals.
  • In collaboration with the DSPV Medical Director, manages risk strategies for all Neurocrine products (all phases of development and post approval).
  • Performs aggregate safety data review and interpretation to support safety evaluations.
  • Leads and provides safety input (e.g., authors and reviews) for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, clinical study reports, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core Data Sheet (CCDS)).
  • Authors, reviews, and provides input to safety related regulatory submission documents including periodic safety reports (e.g., DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and lead in providing responses to regulatory inquiries.
  • Serves as the Safety Scientist Lead for designated indications or drug portfolio(s).
  • Participates in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans.
  • Participates in developing processes and conventions for safety surveillance activities.
  • Manages and mentors staff and assign responsibilities as appropriate to meet timelines and quality metrics.
  • Other duties as assigned.Requirements:
    • BS/BA in related scientific field or RN and 15+ years of experience in pharmacovigilance in the life science industry, with 7+ years of pharmaceutical industry drug safety experience. Experience with use of safety databases, preferably ARISg Safety Database. Experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company with experience in signal management (e.g., signal detection, evaluation, assessment). Experience in preparing responses to regulatory queries on safety-related topics and aggregate analysis of safety data, OR
    • Master's degree in related scientific field and 13+ years of similar experience as show above, OR
    • PharmD or PhD degree in related scientific field and 10+ years of similar experience as show above.
    • Extensive previous managerial experiences required.
    • Ability to conduct individual safety case report processing, including triage, data entry, quality review, and submission.
    • Knowledge of and ability to apply international regulatory authority regulations (especially FDA and EU/EEA).
    • Knowledge of and ability to apply pre- and post-marketing drug safety standards.
    • Proficiency with safety databases (ARISg preferred) and safety coding dictionaries (eg, MedDRA, WHODRUG).
    • Strong leadership and communication skills (both oral and written).
    • Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization.
    • Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively.
    • Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact.
    • Strong leadership and communication skills (both oral and written).
    • Excellent teamwork and interpersonal skills are required.
    • Excellent interpersonal communication skills and ability to work effectively as part of teams.
    • Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.
    • Ability to be flexible, adapt to change, and work independently.#LI-TM1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
      • PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
      • INTEGRITY:We do the right thing for patients and our community. We take accountability. We speak up.
      • COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
      • INNOVATION: We seek and create optimal solutions.
      • TENACITY:We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities! We are a top place to work.
        Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Health Care and Biopharma--- 2021, ranking No. 4 among biopharma companies. In addition, we were also selected as one of the FORTUNE Best Small & Medium Workplaces--- 2020 list, ranking No. 8 out of 100 medium-sized companies across the country. We were also named a Great Place to Work Certified company and were recognized on Great Place to Work's Best Workplaces for Parents--- 2020 list.

Keywords: Neurocrine Biosciences, San Diego , Director, Drug Safety & Pharmacovigilance- Safety Surveillan, Executive , San Diego, California

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