Senior Pharmacovigilance Lead

Precision For Medicine; Peapack-Gladstone (NJ); On-site; USD 110,700 - 166,100; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a seasoned clinical safety professional to lead PV activities across project teams in the United States. You will oversee SAE processing, regulatory reporting, and safety system design, while mentoring Safety Specialists and guiding cross-functional safety initiatives.

You will interact with sponsors and vendors, manage safety budgets, and ensure regulatory alignment through SOPs and training materials.

Qualifications

• BA/BS degree is required.
• 10+ years clinical safety experience.
• 5+ years Pharmacovigilance experience.

Responsibilities

• Interfacing with sponsors, vendors and internal team members in safety/PV to design and implement safety collection tools, processes and reporting systems.
• Assess and set up a safety database to capture SAE data.
• QC of documents and safety reports as needed.
• Prepare and/or review project-specific safety reporting plans and medical coding plans.
• Prepare and/or review safety training materials.
• Review Safety related budget tasks and activities.
• Develop and manage standard operating procedures and work instructions.
• Serve as subject matter expert for department.
• Provide ongoing training and mentorship for Safety Specialists.
• Participate in audits and audit preparation, kick-off meetings, and investigator meetings.
• Participate in CAPA management process.
• Assist with bid defenses for clients.
• Assist management with resource management and oversight.
• Serve as project manager for safety standalone projects.
• Lead departmental initiatives and cross-functional development.
• Support SAE/AESI query generation and tracking including escalation for resolution.
• Review regulatory responses related to safety/pharmacovigilance.

Skills

Communication skills

Analytical skills

Mentorship

Education

BA/BS degree

Tools

MedDRA

WHODrug

Job description

Precision Medicine Group is seeking a seasoned clinical safety professional to lead PV activities across project teams in the United States. You will oversee SAE processing, regulatory reporting, and safety system design, while mentoring Safety Specialists and guiding cross-functional safety initiatives.

You will interact with sponsors and vendors, manage safety budgets, and ensure regulatory alignment through SOPs and training materials.