Neurocrine Biosciences · 3 hours ago
Principal Scientist, Safety
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $179K/yr
4+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Principal Scientist, Safety will provide scientific expertise and support for clinical and post-market pharmacovigilance, including safety evaluations and report preparations for assigned programs.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Safety Scientist Lead for assigned programs or studies. Provides clinical and operational safety support to the Clinical Development programs (eg, content review of protocols, study reports, Investigator Brochure, informed consents and other related documents, as applicable)
Conduct literature review for assigned programs
Lead the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedure 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, 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
Participates in multidisciplinary teams at Neurocrine 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
Qualification
Required
BS/BA or RN degree in 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
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 (eg, MedDRA, WHODRUG)
Expertise in individual safety case report processing, including triage, data entry, quality review, and submission
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/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)
Preferred
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
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
2025-12-24
Company data provided by crunchbase