Principal Safety Scientist- San Diego based

Who We Are:At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.What We Do:Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.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 (eg, 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.Your Contributions (include, but are not limited to):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 programsLead the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedure for assigned programsIn collaboration with the DSPV Medical Director, performs aggregate safety data review and interpretation to support safety evaluations for assigned programsIn collaboration with the DSPV Medical Director, perform signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programsParticipate in independent Data Monitoring Committee meetings, as applicableContribute to SOP and guidelines development and revisionsParticipates in multidisciplinary teams at Neurocrine involving R & D project teams, Clinical Operations, Regulatory, and others to execute clinical trialsSupport DSPV Operations with case processing activities as neededOther duties as assignedRequirements: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. Healthcare professional and vendor management experience preferred ORMaster's degree in related scientific field and 6+ years of similar experience noted above ORPhD or PharmD in related scientific field and 4+ years of similar experience noted aboveStrong knowledge of US and EU pharmacovigilance regulatory requirementsStrong knowledge of current pharmacovigilance practicesKnowledge of drug safety databases; experience with ARISg is a plusAbility to evaluate, interpret and synthesize scientific dataProficiency with safety coding dictionaries (eg, MedDRA, WHODRUG)Expertise in individual safety case report processing, including triage, data entry, quality review, and submissionRequires 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 impactIdentifies and resolves technical, operational and organizational problems relating to own disciplineFrequently works cross-functionally as the representative for their areaTeam player with ability to function in a multi-disciplinary environmentSelf-motivated, detail oriented, and able to prioritize and plan effectivelyStrong leadership and communication skills (both oral and written)Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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