Manager of Patient Safety and Pharmacovigilance (PV) Operations, Contractor (Office OR Remote)

Arcus Biosciences; Hayward (CA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in the biopharmaceutical industry is seeking a Manager of Patient Safety and Pharmacovigilance (PV) Operations. This role involves overseeing safety case processing, vendor management, and cross-functional support to ensure compliance and quality in clinical trials. The ideal candidate will have a strong background in clinical safety operations and effective communication skills, contributing to the company's growth and expansion.

Qualifications

• 4-6+ years in Clinical Safety Operations.
• Oncology experience is preferred.

Responsibilities

• Support vendor management and oversight of safety case processing.
• Provide safety operational support to clinical trial teams.
• Conduct quality control of safety cases processed by vendors.

Skills

Communication

Organizational Skills

Collaboration

Education

Bachelor’s degree in nursing

Bachelor’s degree in pharmacy

Bachelor’s degree in related health field

Tools

Argus

MedDRA

Job description

Job Title: Manager of Patient Safety and Pharmacovigilance (PV) Operations

The Manager of Patient Safety and Pharmacovigilance (PV) Operations will support the development, management, and oversight of safety case processing and safety reporting activities performed by external vendors and CROs. The role involves safety case management, database configuration, site reporting, SAE reconciliation, and safety reporting. The ideal candidate is self-motivated, with strong clinical trial case management and safety leadership experience.

Note: This is a one-year contract.

The responsibilities will support the achievement of corporate and departmental goals, contributing to the company's growth and expansion.

Key Responsibilities

Vendor Oversight

• Support vendor management and oversight of safety case processing and reporting activities.
• Review safety vendor project plans and ensure process documentation.
• Provide guidance on safety operations to vendors and CROs.
• Monitor vendor deliverables and ensure compliance with timelines.
• Ensure timely submission of safety reports through effective vendor management.
• Conduct quality control of safety cases processed by vendors.
• Oversee safety database support, including updates and study configurations.
• Support safety data exchange with partners per SDEAs/PVAs.

Cross-Functional Support

• Provide safety operational support to clinical trial teams.
• Collaborate with Data Management on SAE reconciliation.
• Partner with Safety Quality and Compliance for inspection readiness.
• Support global filing activities and audit preparations.
• Escalate and investigate safety noncompliance issues.

Qualifications

• Bachelor’s degree in nursing, pharmacy, or related health field.
• 4-6+ years in Clinical Safety Operations.
• Experience with Argus, MedDRA, and document management systems.
• Knowledge of FDA, EMA, MHRA regulations, and ICH guidelines.
• Proven vendor oversight success.
• Effective in dynamic, fast-paced environments.
• Excellent communication and organizational skills.
• Safety project management experience.
• Strong cross-functional collaboration skills.
• Oncology experience is preferred.

EEO Statement

Arcus Biosciences is an Equal Opportunity Employer committed to diversity and inclusion. We prohibit discrimination based on race, religion, gender, age, disability, veteran status, or any other protected class.

Physical Requirements

Must be able to work in an office setting with standard equipment, read printed and digital materials, communicate effectively, and occasionally lift up to 25 pounds.