Senior Pharmacovigilance Operations Lead

The Steely Group; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

The Steely Group is seeking a Consultant Manager, Pharmacovigilance to oversee PV operations, case management, and vendor oversight for clinical trials and post-marketing safety activities. You will collaborate with PV and cross-functional teams to ensure quality, compliance, and timely safety reporting.

You will lead safety operations, vendor relationships, and development of PV policies, while supporting audits and regulatory inquiries.

Qualifications

• Bachelor’s or advanced degree in life sciences or healthcare.
• Minimum 5–7 years of direct pharmacovigilance experience.
• Experience with safety databases (ARGUS, ARISg, or other safety database applications), EDC systems, and electronic document management systems.
• Knowledge of GCPs, ICH guidelines and FDA/EMA/international regulations.
• Working knowledge of MedDRA and WHO Drug dictionaries.
• Experience with onboarding, overseeing and managing safety vendors.
• ICSR submission experience is highly preferred.
• Strong interpersonal and communication skills; proactive approach.
• Detail-oriented with good organizational, prioritization, and time management skills.
• Proficient in Word, Excel, and PowerPoint; familiarity with safety database configuration/validation is desirable.

Responsibilities

• Provide oversight of PV operational and case management activities for safety reporting.
• Escalate issues to management as needed.
• Lead PV vendor management oversight activities including day-to-day oversight and vendor performance review.
• Generate performance and compliance metrics for PV vendors and monitor trends.
• Lead safety operations support on assigned studies.
• Contribute to safety documentation such as Safety Management Plans and reporting forms.
• Support Regulatory Authority inspections and audits as subject matter expert.
• Collaborate to develop processes and training for Patient Support Programs and Market Research.

Skills

Pharmacovigilance

Vendor management

Team collaboration

GCP/ICH compliance

MedDRA/WHO dictionaries

ICSR submission

Safety databases (ARGUS/ARISg)

EDC systems

Electronic document management

MS Office

Regulatory knowledge

Education

Bachelor's or advanced degree in life sciences or healthcare

MD/PhD/PharmD (optional)

Tools

ARGUS/ARISg

EDC systems

Electronic document management

MS Office

Job description

The Steely Group is seeking a Consultant Manager, Pharmacovigilance to oversee PV operations, case management, and vendor oversight for clinical trials and post-marketing safety activities. You will collaborate with PV and cross-functional teams to ensure quality, compliance, and timely safety reporting.

You will lead safety operations, vendor relationships, and development of PV policies, while supporting audits and regulatory inquiries.