Senior Pharmacovigilance (PV) Clinical Scientist

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

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Scientific writing

Cross-functional collaboration

Project management

Communication skills

Ausbildung

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

Tools

Argus

ARISg

Jobbeschreibung

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 Position

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 ICSEs 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.

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. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

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.