PV Operations Manager - Pharmacovigilance (Contractor)

Apex Systems, LLC; Waltham (MA); On-site; USD 229,233,000 - 260,752,000; Full time

Job summary

Apex Systems, LLC seeks a Consultant Manager of Pharmacovigilance Operations in Waltham, MA to oversee safety case management and PV vendor oversight for global programs. You will partner with Medical Affairs, Commercial, and external vendors to ensure high‑quality safety reporting and regulatory compliance.

Responsibilities include leading PV case management, SAE reconciliation, and developing safety documents.

Qualifications

• Bachelor’s or advanced degree in life sciences or healthcare.
• 5–7+ years of pharmacovigilance experience.
• Proficient with safety databases (ARGUS, ARISg), EDC, and document management tools.
• Strong knowledge of GCP, ICH, FDA/EMA regulations, MedDRA, and WHO Drug.

Responsibilities

• Oversee PV case management, safety reporting, and compliance monitoring for investigational and commercial products.
• Lead day-to-day PV vendor oversight, performance evaluation, and quality monitoring.
• Support safety operations for assigned clinical studies, including SAE reconciliation.
• Contribute to Safety Data Exchange Agreements and PV-related partner/vendor contracts.
• Develop safety-related study documents and support regulatory inspections and health authority requests.
• Maintain PV system policies and SOPs in alignment with evolving global regulations.

Skills

Pharmacovigilance

Vendor management

Regulatory knowledge

Communication skills

Education

Bachelor’s or advanced degree in life sciences

Tools

ARGUS

ARISg

EDC systems

Document management tools

Job description

Apex Systems, LLC seeks a Consultant Manager of Pharmacovigilance Operations in Waltham, MA to oversee safety case management and PV vendor oversight for global programs. You will partner with Medical Affairs, Commercial, and external vendors to ensure high‑quality safety reporting and regulatory compliance.

Responsibilities include leading PV case management, SAE reconciliation, and developing safety documents.