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

Arcus Biosciences; Brisbane (CA); Hybrid; USD 100,000 - 130,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Manager of Patient Safety and Pharmacovigilance Operations. The ideal candidate will oversee safety case processing and reporting, ensuring compliance with industry regulations while supporting clinical trial teams. This role offers a unique opportunity to contribute to the company's growth and expansion efforts.

Qualifications

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

Responsibilities

• Manage and oversee safety case processing and reporting activities.
• Provide safety operational support to clinical trial teams.
• Ensure timely submission of safety reports.

Skills

Clinical Safety Operations

Vendor Oversight

Safety Project Management

Education

Bachelor’s degree in nursing

Bachelor’s degree in pharmacy

Bachelor’s degree in related health care field

Tools

Argus

MedDRA

document management tools

QC tools

Job description

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

Join to apply for the Manager of Patient Safety and Pharmacovigilance (PV) Operations, Contractor (Office OR Remote) role at Arcus Biosciences.

Description

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 safety vendors and CROs. Key responsibilities include safety case management, safety database configuration, site reporting of safety events, study start-up and close-out activities, SAE reconciliation, and safety reporting. The ideal candidate is self-motivated with strong experience in clinical trial case management and safety operations.

Note: This is a one-year contract.

The role supports the company's goals in growth and expansion.

Key Responsibilities

Vendor Oversight

• Manage and oversee safety case processing and reporting activities by vendors and CROs.
• Review safety project plans and ensure documentation and process adherence.
• Provide guidance to vendors and CROs on safety operations.
• Monitor vendor deliverables and ensure compliance with timelines.
• Ensure timely submission of safety reports and conduct quality control of safety cases.
• Oversee safety database support and updates, including MedDRA and WHO Drug.
• Support safety data exchange with partners per SDEAs/PVAs.

Cross-Functional Support

• Provide safety operational support to clinical trial teams.
• Resolve discrepancies between safety and clinical databases.
• Assist in audit preparations and inspection readiness.
• Support global filing activities and escalate safety non-compliance issues.

Qualifications

• Bachelor’s degree in nursing, pharmacy, or related health care field.
• 4-6+ years’ experience in Clinical Safety Operations.
• Proficiency with Argus, MedDRA, document management, and QC tools.
• Knowledge of FDA, EMA, MHRA, and Asia-PAC regulations, ICH guidelines.
• Experience in vendor oversight and safety project management.
• Oncology experience is preferred.

Additional Information

Arcus Biosciences is an Equal Opportunity Employer. The physical requirements include standard office activities, with the ability to lift up to 25 pounds.