Pharmacovigilance Scientist 2

The Pharmacovigilance Scientist 2 serves as signal detection and literature lead or back-up, contributing to ongoing literature safety surveillance for marketed and investigational products. This includes evaluating events of special interest and reviewing aggregate data. The role focuses on proactive risk identification and characterization.

Day-to-day responsibilities involve authoring and finalizing aggregate reports like PBRERs/PSURs, DSURs, and ACOs, as well as responses to regulatory agency or PRAC inquiries. As molecule lead, handle signal management deliverables, validation, and evaluation per approved strategies. Ensure full documentation and tracking of signals.

In the team environment, oversee end-to-end molecule work, distribute tasks among molecule scientists, and liaise with clinical science scientists, process leads, and cross-functional stakeholders. Maintain in-depth knowledge of the molecule and disease area. Coordinate support across molecules during workload peaks and troughs.

Ensure quality of deliverables with hands-on involvement, resolve issues, and participate in audits and inspections. Adhere to IQVIA and customer SOPs, completing required training timely. Conduct regular lessons learned to cascade customer information to team members.