Principal Scientist, Safety

Role Summary

Principal Scientist, Safety responsible for scientific/clinical expertise and strategic input for clinical and post-market pharmacovigilance, including safety evaluations, signal management, and periodic safety reports for assigned programs.

Responsibilities

• Safety Scientist Lead for assigned programs or studies, providing clinical and operational safety support to Clinical Development (e.g., protocol reviews, study reports, Investigator Brochure, informed consents).
• Conduct literature reviews for assigned programs.
• Lead preparation of periodic safety reports (e.g., PADER, DSURs) per regulatory requirements and SOPs.
• Collaborate with the DSPV Medical Director on aggregate safety data review and interpretation to support safety evaluations.
• Collaborate with the DSPV Medical Director on signal detection and evaluation activities per SOPs and guidelines.
• Participate in independent Data Monitoring Committee meetings, as applicable.
• Contribute to SOP and guidelines development and revisions.
• Participate in multidisciplinary Neurocrine teams to execute clinical trials.
• Support DSPV Operations with case processing activities as needed.
• Other duties as assigned.

Qualifications

• BS/BA or RN in a related scientific field with 8+ years of drug safety experience; 3+ years in pharmacovigilance compliance; experience with ARISg; healthcare professional and vendor management preferred, or
• Master's degree with 6+ years of related experience, or
• PhD or PharmD with 4+ years of related experience.

Skills

• Strong knowledge of US and EU pharmacovigilance regulatory requirements.
• Strong knowledge of current pharmacovigilance practices.
• Knowledge of drug safety databases; ARISg is a plus.
• Ability to evaluate, interpret and synthesize scientific data.
• Proficiency with safety coding dictionaries (e.g., MedDRA, WHODRUG).
• Expertise in individual safety case processing (triage, data entry, quality review, submission).
• Cross-functional collaboration and problem-solving in a multidisciplinary environment.
• Leadership and communication skills (oral and written).

Education

• Bullet points above cover degree requirements; include any advanced degrees as needed.

Additional Requirements

• No additional travel/physical demands specified as essential in source.