Senior Safety Lead & PV Program Manager

Precision Medicine Group; Northern (KY); Hybrid; USD 111,000 - 166,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings

Life insurance

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a senior safety lead to manage clinical safety and pharmacovigilance oversight in a fast-paced environment within the United States. You will oversee SAE processing, safety reporting plans, audits, and cross-functional initiatives while contributing to budget and resource management.

You should have 10+ years in clinical safety and 5+ years PV experience, with nursing or pharmacy degree preferred, and strong regulatory knowledge.

Qualifications

• 10+ years clinical safety experience.
• 5+ years Pharmacovigilance (PV) experience.
• Hands-on experience with global safety databases and SAE processing.
• Working knowledge of MedDRA and WHODrug.
• Understanding of FDA safety regulations, ICH guidelines, and global regulations.
• Excellent written and verbal communication.

Responsibilities

• Interface with sponsors, vendors, and internal teams in safety/PV to design safety collection tools and reporting systems.
• Assist in set-up of a safety database to capture SAE data.
• QC safety documents and reports as needed.
• Prepare and/or review project-specific safety reporting and coding plans.
• Develop SOPs and work instructions; provide training for Safety Specialists.
• Support audits and investigator meetings; participate in CAPA management.
• Lead safety projects and cross-functional initiatives; support client needs.

Skills

Clinical safety experience

Pharmacovigilance experience

Safety database knowledge

Regulatory knowledge (FDA/ICH)

Communication skills

Education

Nursing or Pharmacy degree

Tools

MedDRA

WHODrug

Global safety databases

Job description

Precision Medicine Group is seeking a senior safety lead to manage clinical safety and pharmacovigilance oversight in a fast-paced environment within the United States. You will oversee SAE processing, safety reporting plans, audits, and cross-functional initiatives while contributing to budget and resource management.

You should have 10+ years in clinical safety and 5+ years PV experience, with nursing or pharmacy degree preferred, and strong regulatory knowledge.