Lead Pharmacovigilance Scientist & Safety Strategy Director

The Steely Group; Massachusetts; Hybrid; USD 170,000 - 230,000; Full time

Job summary

The Steely Group is seeking an Associate Director, Pharmacovigilance Scientist to lead PV activities for assigned products, partnering with Safety Physicians and cross-functional teams. This role emphasizes data analysis, signal management, and regulatory submissions to support NDA/MAA filings.

The candidate should bring 5–6 years PV experience, advanced clinical or scientific degrees, and strong communication skills to mentor juniors and drive safety science initiatives across programs.

Qualifications

• Minimum 5-6 years PV experience with leadership exposure.
• Experience in analysis and interpretation of medical and scientific data.
• Experience leading signal management activities and aggregate reports.

Responsibilities

• Serves as lead PV Scientist for assigned product(s) – 60%.
• Conducts signal detection, evaluation, and management with data coordination and analysis.
• Leads and manages DSURs, PADERs, PBRERs preparation and reviews.
• Leads and manages risk management plans.
• Performs literature surveillance and prepares safety governance materials.
• Contributes to safety-related regulatory queries and analyses.
• Contributes to safety analyses for regulatory filings (NDAs/MAAs).
• Supports inspection readiness as SME during audits/inspections.
• Leads strategic innovations and process improvements across products.

Skills

PV data analysis

Lead signal management

Regulatory submissions

Communication

Mentorship

Education

Advanced degree (PharmD, MD, PhD, MPH)

Tools

Argus Safety

MS Office

Job description

The Steely Group is seeking an Associate Director, Pharmacovigilance Scientist to lead PV activities for assigned products, partnering with Safety Physicians and cross-functional teams. This role emphasizes data analysis, signal management, and regulatory submissions to support NDA/MAA filings.

The candidate should bring 5–6 years PV experience, advanced clinical or scientific degrees, and strong communication skills to mentor juniors and drive safety science initiatives across programs.