Director, Pharmacovigilance Scientist at Cullinan Oncology

📋 Description

• Provide PV life-cycle support for assigned products and participate in clinical study teams.
• Represent PV as PV lead in cross-functional teams (SMT, SRC) 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.

🎯 Requirements

• 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
• Led authoring of DSURs for regulatory compliance

🎁 Benefits

• Annual bonus opportunity (25% of salary)
• Equity awards
• Medical, dental, vision, life and disability insurance
• 401(k) plan with employer match
• Stock options and employee stock purchase plan
• Generous PTO, paid holidays and parental leave