Pharmacovigilance Scientist

Provide PV life-cycle support for assigned products and participate in clinical study teams. Represent PV as PV lead in cross-functional teams and with CROs. Perform ongoing ICSR quality review per SOPs and study Safety Plans. Perform signal detection and evaluation; deliver safety analyses and reports. Author DSURs and respond to health authority safety queries. Collaborate with Clinical/Medical teams to communicate safety concerns and escalate issues.

Key Responsibilities

• Provide PV life-cycle support for assigned products
• Represent PV as PV lead in cross-functional teams and with CROs
• Perform ongoing ICSR quality review per SOPs and study Safety Plans
• Perform signal detection and evaluation
• Author DSURs and respond to health authority safety queries

Required Skills & Qualifications

• MS, PhD, or PharmD
• 5+ years PV/drug safety in early development
• Immunology/oncology focus; CART-cell or T cell engagers preferred
• Ability to use Argus safety system for case review and simple queries
• Knowledge of ICH, EMA GVP, FDA IND/NDA, CIOMS