PV Operations Lead - Vendor Oversight & Compliance

The Steely Group; Massachusetts; Hybrid; USD 130,000 - 170,000; Full time

Job summary

The Steely Group seeks a Consultant Manager, Pharmacovigilance (PV) Operations to lead safety case processing, vendor oversight, and cross-functional collaboration across clinical trials and post-marketing activities.

You will manage multiple safety projects, ensure regulatory compliance, drive performance metrics with PV vendors, and support inspections with internal teams. The role is based in Massachusetts and reports to the Senior Manager/Manager, Pharmacovigilance.

Qualifications

• Minimum 5–7 years of direct pharmacovigilance experience.

Responsibilities

• Provide oversight of PV operational and case management activities for safety reporting across investigational and commercial products.
• Escalate issues to management as needed.
• Lead PV vendor management oversight activities including day-to-day oversight and vendor performance evaluation.
• Generate performance and compliance metrics for PV vendors and monitor trends.
• Lead safety operations support on assigned studies.
• Contribute to development of Safety Data Exchange Agreements and PV agreements with partners and vendors.
• Support SAE reconciliation on assigned studies.
• Collaborate to prepare documents related to safety case processing and reporting (e.g., Safety Management Plan, reporting forms).
• Collaborate with internal teams to prepare for regulatory inspections and audits as PV SME.
• Contribute to safety requests from Regulatory Authorities.
• Support PV System policies, SOPs, and guidance documents to ensure regulatory compliance.
• Review new PV regulations for internal procedure updates.
• Coordinate with Medical Affairs/Commercial/Marketing to support patient programs and studies.
• Other responsibilities as assigned

Skills

PV Operations

Vendor Management

Regulatory Compliance

Cross-functional Collaboration

Project Management

Education

Bachelor's or higher in life sciences

Tools

ARGUS

ARISg

EDC Systems

MedDRA

Job description

The Steely Group seeks a Consultant Manager, Pharmacovigilance (PV) Operations to lead safety case processing, vendor oversight, and cross-functional collaboration across clinical trials and post-marketing activities.

You will manage multiple safety projects, ensure regulatory compliance, drive performance metrics with PV vendors, and support inspections with internal teams. The role is based in Massachusetts and reports to the Senior Manager/Manager, Pharmacovigilance.