Principal Scientist, Safety

Role Summary

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.

Responsibilities

• 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 programs
• Lead the preparation of periodic safety reports (eg, PADER, DSURs) in accordance with regulatory requirements and standard operating procedure for assigned programs
• In collaboration with the DSPV Medical Director, performs aggregate safety data review and interpretation to support safety evaluations for assigned programs
• In collaboration with the DSPV Medical Director, perform signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs
• Participate in independent Data Monitoring Committee meetings, as applicable
• Contribute to SOP and guidelines development and revisions
• Participates in multidisciplinary teams at Neurocrine involving R & D project teams, Clinical Operations, Regulatory, and others to execute clinical trials
• Support DSPV Operations with case processing activities as needed
• Other duties as assigned

Qualifications

• 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 OR
• Master's degree in related scientific field and 6+ years of similar experience noted above OR
• PhD or PharmD in related scientific field and 4+ years of similar experience noted above
• Strong knowledge of US and EU pharmacovigilance regulatory requirements
• Strong knowledge of current pharmacovigilance practices
• Knowledge of drug safety databases; experience with ARISg is a plus
• Ability to evaluate, interpret and synthesize scientific data
• Proficiency with safety coding dictionaries (eg, MedDRA, WHODRUG)
• Expertise in individual safety case report processing, including triage, data entry, quality review, and submission
• Requires 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 impact
• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
• Frequently works cross-functionally as the representative for their area
• Team player with ability to function in a multi-disciplinary environment
• Self-motivated, detail oriented, and able to prioritize and plan effectively
• Strong leadership and communication skills (both oral and written)

Skills

• Clinical safety and pharmacovigilance expertise
• Data interpretation and safety signal evaluation
• Regulatory knowledge (US/EU)
• Safety data management and coding (MedDRA, WHODRUG)
• Documentation and report writing (PADER, DSUR)
• Cross-functional collaboration and communication

Education

• BS/BA or RN (or higher) in a related scientific field; advanced degrees preferred