Principal Scientist, Safety

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline of compounds in mid- to late-phase clinical development.

About the Role

Provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with clinical and post-market pharmacovigilance. Support signal management activities, safety and benefit-risk evaluations, and author periodic safety reports (e.g., PADER, DSUR, etc.) for assigned programs. Will be a key contributor to SOP development and revisions. May also work with the DSPV Operations group and assist with case processing activities as needed by the department.

Responsibilities

• Safety Scientist Lead for assigned programs or studies, providing clinical and operational safety support to Clinical Development programs (e.g., content review of protocols, study reports, Investigator Brochure, informed consents, and other related documents).
• Conduct literature review for assigned programs.
• Lead 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, perform aggregate safety data review and interpretation to support safety evaluations for assigned programs.
• Perform signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs.
• Participate in independent Data Monitoring Committee meetings, as applicable.
• Contribute to SOP and guidelines development and revisions.
• Participate in multidisciplinary teams involving R&D project teams, Clinical Operations, Regulatory, and others to execute clinical trials.
• Support DSPV Operations with case processing activities as needed.
• Other duties as assigned.

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

Pay

The annual base salary we reasonably expect to pay is $130,800.00 - $179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity-based long-term incentive program.

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 in accordance with the terms and conditions of the applicable plans.