Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
As a Senior Pharmacovigilance (PV) Clinical Scientist in our US Patient Safety organization, you will play a pivotal role in safeguarding patient wellbeing and ensuring strict regulatory compliance across our commercial and pipeline portfolio. You will operate with high autonomy, applying your deep clinical judgment to evaluate complex adverse event data, partner across multidisciplinary matrix teams, and oversee external vendor quality. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Lead clinical review and medical evaluation of Individual Case Safety Reports (ICSRs) across in-house and vendor-processed channels, executing rigorous seriousness, expectedness, and causality assessments
- Perform high-accuracy clinical data entry and oversight within the Roche global safety database, ensuring case processing integrity and adherence to stringent labeling conventions
- Drive end-to-end regulatory submission excellence by ensuring ICSRs and aggregate safety data strictly align with FDA, EMA, MHRA, and ICH compliance benchmarks and filing timelines
- Direct cross-functional vendor oversight initiatives, analyzing case quality metrics, tracking discrepancy trends, and conducting case transmission verifications
- Lead continuous quality improvement initiatives, authoring and maintaining standard operating procedures (SOPs), working instructions, and auditor-ready training curricula
- Oversee Technical Product Complaints (TPC) and Medical Product Complaints (MPC) with associated adverse events, managing correspondence workflows and systematic follow-up investigations
More about this role
Why Genentech
We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society.
The Opportunity
As a Senior Pharmacovigilance (PV) Clinical Scientist in our US Patient Safety organization, you will play a pivotal role in safeguarding patient wellbeing and ensuring strict regulatory compliance across our commercial and pipeline portfolio. You will operate with high autonomy, applying your deep clinical judgment to evaluate complex adverse event data, partner across multidisciplinary matrix teams, and oversee external vendor quality. In this role, you will champion operational excellence and uphold rigorous safety standards that directly impact patient outcomes.
- Lead clinical review and medical evaluation of Individual Case Safety Reports (ICSRs) across in-house and vendor-processed channels, executing rigorous seriousness, expectedness, and causality assessments.
- Perform high-accuracy clinical data entry and oversight within the Roche global safety database,...
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