Senior Pharmacovigilance & Safety Lead

Precision Medicine Group; Peapack-Gladstone (NJ); On-site; USD 111,000 - 166,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Job summary

Precision Medicine Group is seeking a senior safety professional to oversee pharmacovigilance activities, manage safety databases, and provide expert safety input for client projects. The role includes training staff, participating in audits, and shaping safety reporting processes.

Minimum 10+ years in clinical safety with PV experience is required, plus strong regulatory knowledge and communication skills.

Qualifications

• BA/BS degree.
• 10+ years clinical safety experience.
• 5+ years Pharmacovigilance (PV) experience.

Responsibilities

• Interface with sponsors, vendors and internal team in safety/PV.
• Set up safety database to capture SAE data.
• QC safety reports and documents as needed.
• Lead safety training and SOP development.
• Mentor Safety Specialists and support audits.
• Assist regulatory responses for safety questions.

Skills

Clinical safety

Pharmacovigilance

Regulatory knowledge

Communication skills

Project management

Education

BA/BS degree

Tools

MedDRA

WHODrug

Job description

Precision Medicine Group is seeking a senior safety professional to oversee pharmacovigilance activities, manage safety databases, and provide expert safety input for client projects. The role includes training staff, participating in audits, and shaping safety reporting processes.

Minimum 10+ years in clinical safety with PV experience is required, plus strong regulatory knowledge and communication skills.