Principal Safety Scientist

2 weeks ago


San Diego, California, United States Neurocrine Biosciences Full time
About the Role

We are seeking a highly skilled Principal Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our Clinical Development group, you will provide scientific and clinical expertise to support the development of our life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders.

Key Responsibilities
  • Provide clinical and operational safety support to our Clinical Development programs, including content review of protocols, study reports, and informed consents.
  • Conduct literature reviews and lead the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedures.
  • Collaborate with our DSPV Medical Director to perform aggregate safety data review and interpretation, as well as signal detection and evaluation activities.
  • Participate in independent Data Monitoring Committee meetings and contribute to SOP and guidelines development and revisions.
  • Support our DSPV Operations team with case processing activities as needed.
Requirements
  • BS/BA or RN degree in a related scientific field and 8+ years of experience in drug safety in the biotech/pharmaceutical industry, with 3+ years of pharmacovigilance compliance experience.
  • Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices.
  • Ability to evaluate, interpret, and synthesize scientific data, with proficiency in safety coding dictionaries and expertise in individual safety case report processing.
  • Strong leadership and communication skills, with the ability to function in a multi-disciplinary environment and prioritize and plan effectively.
What We Offer

At Neurocrine Biosciences, we are committed to building a diverse, equitable, and inclusive workplace. We recognize the value of our employees and offer a competitive compensation package, as well as opportunities for professional growth and development.



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