Regional Senior Analyst – Pharmacovigilance

About the role

The Regional Senior Analyst, Pharmacovigilance will ensure that all pharmacovigilance activities across the assigned Pan‑American region comply with local laws, regulations and Knight procedures. Working closely with the PV manager and cross‑functional teams, the analyst supports internal projects and may act as the Qualified Person for Pharmacovigilance (QPPV) or backup when required.

Key responsibilities

• Process Individual Case Safety Reports (ICSRs) from all sources, code them using MedDRA, protect personal data and perform follow‑up and reconciliation activities.
• Adapt, review and submit periodic safety reports, annual safety reports and Risk Management Plans to Health Authorities.
• Implement approved risk‑management activities, including distribution of materials to health professionals and data collection.
• Train Knight employees and subcontractors on adverse reaction reporting responsibilities.
• Liaise with external pharmacovigilance and patient‑support providers.
• Provide PV support to medical, marketing, access and other departments.
• Open and control deviations and CAPAs related to PV/Medical Information activities.
• Act as QPPV or QPPV backup, handling case processing, expedited reporting, HA submissions, local RMP management and audit representation.

Required profile

• Minimum 5 years of experience in Pharmacovigilance or Medical Information.
• Professional qualification as a Pharmacist, Physician or Pharmaceutical Chemist.
• Demonstrated ability to work collaboratively across regulatory, quality and medical functions.

Required skills

• MedDRA coding
• ICSR processing
• Safety report preparation
• Risk Management Plan development
• Regulatory submission
• CAPA management
• Adverse reaction reporting