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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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.
