Senior Pharmacovigilance Clinical Scientist

About the role

Genentech is hiring a Senior Pharmacovigilance (PV) Clinical Scientist for its US Patient Safety organization. The role safeguards patient wellbeing and ensures strict regulatory compliance across the commercial and pipeline portfolio, with high autonomy and deep clinical judgment applied to complex adverse event data.

Key responsibilities

• Lead clinical review and medical evaluation of Individual Case Safety Reports (ICSRs) across in-house and vendor-processed channels, assessing seriousness, expectedness and causality.
• Perform accurate clinical data entry and oversight in the Roche global safety database, following labeling conventions.
• Ensure ICSRs and aggregate safety data meet FDA, EMA, MHRA and ICH compliance and filing timelines.
• Oversight of vendors: analyze case quality metrics, track discrepancies and verify case transmissions.
• Drive quality improvement, authoring and maintaining SOPs, working instructions and auditor-ready training materials.
• Oversee Technical Product Complaints (TPC) and Medical Product Complaints (MPC) and their adverse events, including follow-up investigations.
• Serve as Patient Safety Subject Matter Expert during internal audits, quality assessments and Health Authority inspections.

Required profile

• Advanced healthcare professional degree (RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD).
• 5 to 7 years of biopharmaceutical experience in pharmacovigilance, or equivalent clinical experience with practical mastery of FDA, EMA and ICH safety regulations.
• Ability to work autonomously and make sound risk-based decisions in fast-paced settings.
• Strong scientific writing, project management and collaboration skills.

Preferred qualifications

• Experience managing Health Authority submissions and workflows in global safety databases such as Argus or ARISg.
• Familiarity with inspection frameworks and PV compliance programs (FDA, EMA GVP).
• Track record leading quality initiatives, Lean/Six Sigma improvements and SOP authorship.

What we offer

• Expected salary range of $120,800 to $224,300 depending on experience, qualifications and location; actual pay set by the company.
• A discretionary annual bonus may be available.
• The position qualifies for the benefits described in the original listing; relocation benefits are not available.