Drug Safety Lead

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. They have a strong focus on Oncology and Rare Disease. The Drug Safety Lead will be responsible for project-specific teleconferences, safety budget review and approval, safety management plan development, and providing safety expertise in a timely manner.

Requirements

• 10+ years clinical safety experience
• 5+ years Pharmacovigilance (PV) experience
• Health care professional
• Hands on experience with global safety database(s), SAE case processing, and safety reports generation
• Working knowledge of MedDRA and WHODrug
• Working knowledge of FDA safety regulations, ICH guidelines, and Global regulations
• Demonstrated knowledge of relevant regulatory agency(s) guidelines governing both Safety reporting and processing for clinical trial environments
• Excellent communication and analytical skills (written and oral)
• Excellent judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient

Benefits

• Paid time off
• Health insurance
• Retirement plan
• Professional development opportunities