Senior Safety / PV Leader Consultant

Senior Safety / Pharmacovigilance (PV) Leader – Consultant

Location: Remote / Flexible

Type: Part-Time Consultant (Expected 15-20 hrs/week)

Therapeutic Area: Pediatric Nephrology

Duration: 12 months 

Our client is seeking a seasoned Safety / PV Leader to serve as a strategic consultant during a critical phase of our clinical development program. With an upcoming NDA submission and a challenging pediatric nephrology trial on the horizon, we require a highly experienced safety expert—ideally a nephrologist or pediatrician—who can lead, advise, and elevate our safety and regulatory deliverables.

This is not a full-time role, but a high-impact consultancy for someone who has “been there, done that” in large pharma and understands the nuances of safety data, regulatory expectations, and clinical trial oversight.

Responsibilities

• Lead safety strategy and oversight for a difficult-to-recruit pediatric nephrology clinical trial.
• Review and refine safety deliverables for NDA submission and regulatory updates.
• Serve as a senior safety authority during regulatory interactions, including 120-day safety updates.
• Provide mentorship and leadership to internal safety team members, elevating document quality and regulatory readiness.
• Act as a trusted advisor for protocol development, safety data interpretation, and agency expectations.

Requirements

• Board-certified nephrologist or pediatrician strongly preferred. Candidates with deep internal medicine experience and safety leadership in large pharma (e.g., Amgen, Pfizer, GSK) will also be considered.
• 20–30 years in pharmacovigilance and drug safety, with a proven track record of leading safety functions and contributing to successful NDA filings.
• Deep Regulatory acumen and understanding of what regulatory agencies expect in safety data and documentation. Able to speak confidently and credibly in regulatory meetings.
• Collaborative, decisive, and able to guide less experienced team members. Comfortable stepping into a leadership vacuum and driving quality.
• Ability to elevate work—not just check boxes. This role demands strategic thinking, precision, and the ability to lead by example.