Lead Pharmacovigilance & Safety Scientist
Aimlroles
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Benefits offered by this job
Job summary
Neurocrine Biosciences in San Diego seeks a Safety Scientist Lead to provide clinical and operational pharmacovigilance support for assigned programs and participate in case processing activities as needed.
You will lead periodic safety reports (PADER, DSUR) and perform aggregate safety data review in collaboration with the DSPV Medical Director, contributing to safety evaluations and regulatory compliance.
Qualifications
- 8+ years drug safety experience in biotech/pharma
- 3+ years pharmacovigilance compliance experience
- Experience with regulatory authority inspections of GVP and process improvement
Responsibilities
- Safety Scientist Lead for assigned programs or studies: review protocols, study reports, Investigator Brochure, informed consents and related docs
- Lead preparation of periodic safety reports (PADER, DSUR)
- Aggregate safety data review and interpretation to support safety evaluations
- Signal detection and evaluation activities per SOPs
- Participate in independent Data Monitoring Committee meetings
- Contribute to SOP and guidelines development and revisions
- Collaborate with cross-functional teams to execute clinical trials
Skills
Education
Tools
Job description
Neurocrine Biosciences in San Diego seeks a Safety Scientist Lead to provide clinical and operational pharmacovigilance support for assigned programs and participate in case processing activities as needed.
You will lead periodic safety reports (PADER, DSUR) and perform aggregate safety data review in collaboration with the DSPV Medical Director, contributing to safety evaluations and regulatory compliance.
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