Safety Lead

📋 Description

• Interface with sponsors/vendors to design safety data collection tools.
• Participate in setup of a safety database to capture SAE data.
• QC of documents and safety reports.
• Prepare/review safety reporting and medical coding plans.
• Develop and manage SOPs and work instructions.
• Provide ongoing training and mentorship for Safety Specialists.

🎯 Requirements

• BA/BS degree.
• 10+ years clinical safety experience.
• 5+ years Pharmacovigilance experience.
• Healthcare professional.
• Hands-on experience with global safety databases, SAE processing, and safety reports generation.
• Working knowledge of MedDRA and WHODrug.

🎁 Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.