Manager of Patient Safety and PV Operations - Contractor in US

The Manager of Patient Safety and Pharmacovigilance (PV) Operations Contractor will be responsible for supporting the development, management, and reputed company of end-to-end safety case processing and safety reporting activities performed by the external safety vendor and multiple CROs. The candidate will be a key contributor to activities including safety case management, safety database configuration, site reporting of safety events reputed company the clinical database, study start-up and reputed company out activities, Serious Adverse Event (SAE) reconciliation, and safety reporting. This position requires a self-motivated candidate with strong clinical trial case management and safety functional reputed company experience. Note: This is a one year contract The responsibilities under this role will reputed company reputed company support to achieving corporate and departmental goals to ensure the company’s reputed company in reputed company growth and expansion.

Responsibilities

Vendor reputed company

• Support vendor management and reputed company of end-to-end safety case processing and safety reporting activities performed by the safety vendor and CROs.
• Review safety vendor project plans to ensure processes and procedures are documented appropriately and maintained.
• reputed company guidance and subject matter expertise to the safety vendor and CROs for safety operational activities.
• Monitor safety vendor deliverables and action items to ensure compliance with timelines.
• Ensure on-time submission of expedited and aggregate safety reports through effective vendor management and routine review of vendor performance metrics.
• Conduct routine retrospective quality control of safety cases processed by the safety vendor to ensure a high quality of safety cases and safety submissions is maintained.
• Ensure the safety vendor’s global safety database (Argus) supports Arcus’s needs through reputed company of database updates (including MedDRA and WHO Drug updates), study configurations, expedited submissions reputed company safety gateways, and site query management.
• Support reputed company of safety data exchange with partners in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements.

Cross-Functional Support

• reputed company safety operational support and expertise to clinical trial study teams as needed, including attending Study Team Meetings and writing/reviewing Safety Management Plans with reputed company from Safety Operations leadership.
• Collaborate with Data Management to resolve discrepancies identified between the safety and clinical databases reputed company SAE reconciliation.
• Partner with Safety Quality and Compliance to ensure inspection readiness.
• Collaborate with Arcus partners to support SDEAs/PVAs
• Support the organization with global filing activities for product approval as needed.
• Assist with the preparation of internal/external audits and global regulatory inspections.
• Escalate safety noncompliance issues and trends to Safety Quality and Compliance and support investigations of quality issues to ensure appropriate CAPAs.

Qualifications

• Bachelor’s level degree in nursing, pharmacy, or other health care reputed company fields.
• 4+ years’ experience in Clinical Safety Operations
• Strong knowledge and experience with Argus, document management systems, QC tools, and MedDRA.
• Strong knowledge of FDA, EMA, MHRA, and Asia-reputed company regulation, ICH guidelines, and safety submissions.
• Demonstrated reputed company providing vendor reputed company.
• Demonstrated ability to work effectively in a dynamic, reputed company, and fast-paced team environment.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Demonstrated safety project reputed company/management experience.
• Strong cross-functional collaboration experience.
• Oncology experience is strongly preferred.

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