Senior Pharmacovigilance (PV) Clinical Scientist

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 121,000 - 224,000; Full time

Benefits offered by this job

Relocation benefits not available

Job summary

Genentech is seeking a Senior Pharmacovigilance Clinical Scientist to safeguard patient safety across our US portfolio. You will lead ICSRs review, perform causality assessments, and ensure regulatory submissions meet FDA, EMA and ICH timelines.

You will mentor teams, manage external vendors, and drive quality improvements in a fast-paced environment. This role requires an Advanced Healthcare Professional degree and 5–7 years in pharmacovigilance, with strong scientific writing and

Qualifications

• 5 to 7 years in pharmacovigilance or equivalent clinical practice.
• Strong knowledge of FDA, EMA and ICH safety regulations.
• Experience with ICSRs and medical causality assessment.

Responsibilities

• Lead clinical review and medical evaluation of ICSRs.
• Ensure case processing and regulatory submissions meet timelines.
• Oversee cross-functional vendor oversight and data quality.
• Author SOPs and auditor-ready training materials.

Skills

Clinical judgment

Regulatory knowledge

Cross-functional collaboration

Medical writing

Project management

Education

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

Tools

Argus

ARISg

FDA/EMA/ICH safety regulations

Job description

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, 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. Serve as a Patient Safety Subject Matter Expert (SME) during internal audits, quality assessments, and global Health Authority regulatory inspections.

Who You Are

Advanced Healthcare Professional degree (RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD). Bring 5 to 7 years of biopharmaceutical industry experience dedicated to pharmacovigilance, or equivalent clinical experience coupled with a practical mastery of FDA, EMA, and ICH safety regulations and submission pathways. Demonstrate clinical acumen in evaluating complex adverse events, determining medical causality, and navigating global safety databases. Proven ability to work autonomously with minimal supervision, driving sound risk‑based decisions in fast‑paced operational environments. Exhibit strong scientific writing, cross‑functional project management, and collaborative communication skills.

Preferred Qualifications

• Proven direct experience managing Health Authority submissions and operational workflows inside enterprise global safety databases (e.g., Argus, ARISg).
• Practical familiarity with Health Authority inspection frameworks and PV compliance program methodologies (e.g., FDA Compliance Program Guidance, EMA Pharmacovigilance Inspection Procedures / Good Pharmacovigilance Practices).
• Demonstrated track record of leading quality initiatives, Lean/Six Sigma process improvements, and SOP authorship within a matrixed safety organization.

Salary

The expected salary range for this position based on the primary location of CA is $120,800 and $224, 300. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

• Relocation benefits are note available for this job posting.

Equal Opportunity

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world’s most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.