Pharmacovigilance Safety Scientist

Neurocrine Biosciences; San Diego (CA); On-site; USD 90,000 - 123,000; Full time

Job summary

Neurocrine Biosciences in San Diego, CA, seeks a pharmacovigilance professional to support safety surveillance across product lifecycles. You will help detect signals, analyze data, and prepare safety input for regulatory documents, while working with R&D, regulatory, and clinical teams.

The role emphasizes cross-functional collaboration, adherence to ICH guidelines, and handling PV systems. A strong pharmacovigilance background and attention to detail are essential.

Qualifications

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

Responsibilities

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

Skills

Strong computer skills

Communications and analytical thinking

Detail oriented

Team player

Self-motivated

ICH guidelines knowledge

Pharmacovigilance knowledge

Education

BS/BA degree in related scientific field or RN degree

MS/MA degree in related scientific field

PharmD or PA

Tools

ARISg

Argus

Job description

Neurocrine Biosciences in San Diego, CA, seeks a pharmacovigilance professional to support safety surveillance across product lifecycles. You will help detect signals, analyze data, and prepare safety input for regulatory documents, while working with R&D, regulatory, and clinical teams.

The role emphasizes cross-functional collaboration, adherence to ICH guidelines, and handling PV systems. A strong pharmacovigilance background and attention to detail are essential.