Senior PV Clinical Scientist, Patient Safety

Roche; South San Francisco (CA); Vor Ort; USD 121.000 - 224.000; Vollzeit

Zusammenfassung

Genentech seeks a Senior Pharmacovigilance Clinical Scientist to join the US Patient Safety organization in South San Francisco. You will lead clinical evaluation of ICSRs, ensure regulatory alignment across FDA/EMA/ICH, and oversee vendor quality with autonomy.

You bring 5–7 years in PV or related clinical roles, advanced healthcare degree, and strong scientific writing in a fast-paced matrix environment, contributing to global safety submissions and continuous safety improvements.

Qualifikationen

• Advanced healthcare professional degree (RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD).
• 5–7 years in PV or related clinical experience with FDA/EMA/ICH knowledge.
• Strong ability to evaluate adverse events and navigate safety databases.
• Proven autonomous working style in fast-paced environments.
• Excellent scientific writing and cross-functional communication.

Aufgaben

• Lead clinical review and medical evaluation of ICSRs across channels.
• Oversee data entry and integrity in global safety databases.
• Drive regulatory submission excellence and alignment with milestones.
• Manage vendor oversight, track data quality and discrepancies.
• Author SOPs, trainings, and support audits and inspections.

Kenntnisse

PV experience

Clinical judgment

Regulatory compliance

Cross-functional collaboration

Ausbildung

Advanced healthcare professional degree (RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD)

Tools

Argus

ARISg

Jobbeschreibung

Genentech seeks a Senior Pharmacovigilance Clinical Scientist to join the US Patient Safety organization in South San Francisco. You will lead clinical evaluation of ICSRs, ensure regulatory alignment across FDA/EMA/ICH, and oversee vendor quality with autonomy.

You bring 5–7 years in PV or related clinical roles, advanced healthcare degree, and strong scientific writing in a fast-paced matrix environment, contributing to global safety submissions and continuous safety improvements.