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Principal Safety Scientist

2 months ago

San Diego, California, United States Neurocrine Bioscience 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 pharmacovigilance department, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.

Key Responsibilities
  • Provide scientific and clinical input to support the development of safety protocols and reports
  • Conduct literature reviews and analyze data to identify potential safety signals
  • Lead the preparation of periodic safety reports and aggregate safety data reviews
  • Collaborate with the DSPV Medical Director to perform signal detection and evaluation activities
  • Participate in independent Data Monitoring Committee meetings and contribute to SOP and guidelines development
  • Support DSPV Operations with case processing activities and work with multidisciplinary teams to execute clinical trials
Requirements
  • BS/BA or RN degree in a related scientific field and 8+ years of experience in drug safety in the biotech/pharmaceutical industry
  • 3+ years of pharmacovigilance compliance experience and experience with drug safety databases such as ARISg
  • Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices
  • Ability to evaluate, interpret, and synthesize scientific data and proficiency with safety coding dictionaries
  • Expertise in individual safety case report processing and strong leadership and communication skills
What We Offer

At Neurocrine Biosciences, we are committed to building a diverse, equitable, and inclusive workplace. We recognize the value of a talented and dedicated team and offer a competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.