Scientist, Safety

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Supports safety surveillance and risk management activities for assigned Neurocrine products through the lifecycle of the product. Supports the production of aggregate reports, signal management and safety review meetings, providing safety support for investigational products including new drug applications and other regulatory filings, managing responses to health authorities and maintaining relationships with PV business partners. May also work with the DSPV Operations group to support case processing activities as needed by the department. _

Your Contributions (include, but are not limited to):

Participate in the process of safety signal management to detect, analyze, and investigate safety signals

Executes risk management plans for assigned Neurocrine products during all phases of development and post approval

Perform assigned safety data review and may interpret information to support safety evaluations

Support preparation of safety input (e.g., author and review) for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core Data Sheet (CCDS))

Assist preparation of safety related regulatory submission documents including periodic and ad-hoc aggregate reports (eg, DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and safety-related health authority requests in accordance with regulatory requirements

Participate in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans

Participate in testing processes and conventions for safety surveillance activities including maintenance of SOPs and guidelines

Collects responses to safety questions from internal and external stakeholders including business partners

Perform review of scientific literature for safety information

Support clinical trial PV activities including providing safety content review of clinical protocols, study reports, Investigators Brochure, informed consents and other related documents, as applicable

Assist with document requests and preparing responses during inspections and audits as well as management of any corrective and preventative actions

Other duties as assigned

Requirements:

BS/BA degree in related scientific field or RN degree AND 2+ years of pharmacovigilance or clinical and/or medical research or equivalent experience OR

MS/MA degree in related scientific field AND some relevant industry experience preferred OR

PharmD or PA AND some experience preferred

Recognizes fundamental anomalies in data points and identifies issues in experiments / processes

Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals

Strong knowledge of one scientific discipline

Good knowledge of scientific principles, methods and techniques

Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools

Ability to work as part of a team

Strong computer skills

Good communications, problem-solving, analytical thinking skills

Detail oriented

Team player with ability to function in a multi-disciplinary environment

Self-motivated, detail oriented, and able to prioritize and plan effectively

Knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements

Working knowledge of drug safety systems (e.g. ARISg and Argus)

Knowledge of current pharmacovigilance practices

Shows ability to evaluate, interpret and synthesize scientific data

Knowledge of signal evaluation and risk management

Working knowledge of aggregate data analysis, interpretation and synthesis

Ability to review periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs

Good knowledge of current pharmacovigilance practices

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment , 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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The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. 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 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.