Senior PV Clinical Scientist & Patient Safety Leader

Genentech, Inc.; South San Francisco (CA); In loco; USD 121.000 - 224.000; Tempo pieno

Descrizione del lavoro

Genentech, located in California, seeks a Senior PV Clinical Scientist to safeguard patient safety across our portfolio. You will autonomously evaluate adverse events, manage regulatory submissions, and lead cross-functional safety initiatives.

You will work with internal teams and external partners to ensure data integrity, compliance with FDA/EMA/ICH requirements, and continuous quality improvements in pharmacovigilance practices.

Competenze

• Proven ability to interpret complex safety data and write regulatory communications.
• Experience navigating FDA, EMA, ICH safety regulations and submission pathways.
• Demonstrated track record in pharmacovigilance within biopharma or equivalent.

Mansioni

• Lead clinical review and medical evaluation of ICSRs across in-house and vendor channels.
• Oversee data entry and case processing in global safety databases with high accuracy.
• Drive end-to-end regulatory submissions and ensure alignment with global benchmarks and timelines.
• Direct vendor oversight, trend analysis, and case transmission verification.
• Develop and maintain SOPs, work instructions, and auditor-ready training materials.
• Oversee product complaints and related adverse events and follow-up investigations.
• Support internal audits, quality assessments, and regulatory inspections as SME.

Conoscenze

Scientific writing

Cross-functional collaboration

Project management

Communication skills

Formazione

Advanced Healthcare Professional degree (RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD)

Strumenti

Argus

ARISg

Descrizione del lavoro

Genentech, located in California, seeks a Senior PV Clinical Scientist to safeguard patient safety across our portfolio. You will autonomously evaluate adverse events, manage regulatory submissions, and lead cross-functional safety initiatives.

You will work with internal teams and external partners to ensure data integrity, compliance with FDA/EMA/ICH requirements, and continuous quality improvements in pharmacovigilance practices.