Senior Safety Scientist – Pharmacovigilance Lead & DSUR Expert

Neurocrine Biosciences; San Diego (CA); Sur place; USD 131 000 - 179 000; Plein temps

Avantages offerts par ce poste

Retirement savings plan

Paid vacation

Holiday and personal days

Parental and medical leave

Health benefits

Résumé du poste

Neurocrine Biosciences seeks a Safety Scientist Lead to provide scientific, clinical and operational safety input for clinical and post-market pharmacovigilance. You will contribute to SOP development, review study documents, and support case processing as needed.

The role requires 8+ years in drug safety, with expertise in safety databases (ARISg) and regulatory requirements (GVP). A leadership mindset and strong communication are essential.

Qualifications

• 8+ years in drug safety with pharmacovigilance compliance experience.
• Experience supporting regulatory inspections (GVP).
• Experience with ARISg, safety databases and signal detection.

Responsabilités

• Lead safety activities for assigned programs and studies.
• Provide clinical and operational safety support to Clinical Development programs.
• Prepare periodic safety reports (PADER, DSUR) per regulatory requirements.
• Collaborate with DSPV Medical Director on data review and signal evaluation.

Connaissances

Pharmacovigilance

Drug safety

Regulatory knowledge

Leadership

Communication

Safety data systems

Formation

BS/BA or RN in related field

MS/PhD/PharmD preferred

Outils

ARISg

MedDRA/WHODRUG

Description du poste

Neurocrine Biosciences seeks a Safety Scientist Lead to provide scientific, clinical and operational safety input for clinical and post-market pharmacovigilance. You will contribute to SOP development, review study documents, and support case processing as needed.

The role requires 8+ years in drug safety, with expertise in safety databases (ARISg) and regulatory requirements (GVP). A leadership mindset and strong communication are essential.