Principal Scientist, Safety

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. The company has a diverse portfolio and a robust pipeline. This role will provide scientific and clinical expertise, strategic input, and support for clinical and post-market pharmacovigilance activities. The position involves supporting signal management, safety and benefit-risk evaluations, and authoring periodic safety reports. The role may also contribute to SOP development and revisions, and potentially assist with case processing activities.

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.
• Experience in supporting regulatory authority inspections of GVP and process improvement initiatives.
• Experience with drug safety databases such as ARISg.
• Requires understanding of how the team/work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact.
• Identifies and resolves technical, operational, and organizational problems relating to own discipline.
• Frequently works cross-functionally as the representative for their area.
• Team player with ability to function in a multi-disciplinary environment.
• Self-motivated, detail-oriented, and able to prioritize and plan effectively.
• Strong leadership and communication skills (both oral and written).
• Strong knowledge of US and EU pharmacovigilance regulatory requirements.
• Strong knowledge of current pharmacovigilance practices.
• Knowledge of drug safety databases; experience with ARISg is a plus.
• Ability to evaluate, interpret, and synthesize scientific data.
• Proficiency with safety coding dictionaries (e.g., MedDRA, WHODRUG).
• Expertise in individual safety case report processing, including triage, data entry, quality review, and submission.

Nice To Haves

• Healthcare professional and vendor management experience preferred.
• Master's degree in related scientific field AND 6+ years of similar experience noted above.
• PhD or PharmD in related scientific field AND 4+ years of similar experience noted above.

Responsibilities

• Safety Scientist Lead for assigned programs or studies.
• Provides clinical and operational safety support to Clinical Development programs, including content review of protocols, study reports, Investigator Brochure, informed consents, and other related documents.
• Conducts literature reviews for assigned programs.
• Leads the preparation of periodic safety reports (e.g., PADER, DSURs) in accordance with regulatory requirements and standard operating procedures for assigned programs.
• In collaboration with the DSPV Medical Director, performs aggregate safety data review and interpretation to support safety evaluations for assigned programs.
• In collaboration with the DSPV Medical Director, performs signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs.
• Participates in independent Data Monitoring Committee meetings, as applicable.
• Contributes to SOP and guidelines development and revisions.
• Participates in multidisciplinary teams at Neurocrine involving R&D project teams, Clinical Operations, Regulatory, and others to execute clinical trials.
• Supports DSPV Operations with case processing activities as needed.
• Other duties as assigned.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior