Safety Scientist Lead – Pharmacovigilance

Job Description

Principal Scientist, Safety | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, likely located in San Diego, CA. The company is dedicated to discovering, developing, and commercializing treatments for neurological, psychiatric, endocrine, and immunological disorders. This position contributes scientific and clinical expertise to pharmacovigilance, ensuring the safety and benefit-risk evaluation of critical treatments, and plays a key role in developing and maintaining essential safety processes.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person, San Diego, CA
• Pay: $130800–$179000 yearly
• Team: Collaborates with DSPV Medical Directors and multidisciplinary teams across R&D, Clinical Operations, and Regulatory.
• Mission: Owns the scientific and clinical safety expertise for assigned programs, ensuring robust pharmacovigilance and accurate safety reporting.
• Tech Stack: ARISg, MedDRA, WHODRUG

What You’ll Actually Do
• Lead Safety Programs: Serve as the Safety Scientist Lead for assigned programs or studies, providing overall scientific and clinical guidance.
• Ensure Safety Reporting: Lead the preparation of all periodic safety reports, such as PADERs and DSURs, in full compliance with regulatory requirements and standard operating procedures.
• Perform Safety Evaluations: Collaborate with DSPV Medical Directors to conduct aggregate safety data review, interpretation, signal detection, and benefit-risk evaluations for assigned programs.
• Support Clinical Development: Provide essential clinical and operational safety support to Clinical Development programs, including content review for protocols, study reports, and informed consents.
• Develop Standards: Actively contribute to the development and revision of Standard Operating Procedures (SOPs) and guidelines for pharmacovigilance practices.

The Must-Haves
• Background: BS/BA or RN degree in a related scientific field with expertise in drug safety and pharmacovigilance, or a Master’s degree with 6+ years, or a PhD/PharmD with 4+ years of relevant experience.
• Experience: 8+ years in drug safety within the biotech/pharmaceutical industry, including 3+ years in pharmacovigilance compliance, supporting regulatory authority inspections of GVP, and process improvement initiatives.
• Skills: Strong knowledge of US and EU pharmacovigilance regulatory requirements and practices; ability to evaluate, interpret, and synthesize scientific data; proficiency with safety coding dictionaries (MedDRA, WHODRUG); expertise in individual safety case report processing.
• Bonus: Healthcare professional and vendor management experience.