Senior Pharmacovigilance (PV) Clinical Scientist

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.