Manager, Patient Safety and PV Operations - Contractor in US
Description
The Manager of Patient Safety and Pharmacovigilance (PV) Operations Contractor will be responsible for supporting the development, management, and oversight 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 via the clinical database, study start-up and close 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 lead experience.
Note: This is a one year contract
The responsibilities under this role will provide continuous support to achieving corporate and departmental goals to ensure the company’s success in continued growth and expansion.
Responsibilities
Vendor Oversight
- Support vendor management and oversight 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.
- Provide 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 oversight of database updates (including MedDRA and WHO Drug updates), study configurations, expedited submissions via safety gateways, and site query management.
- Support oversight of safety data exchange with partners in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements.
Cross-Functional Support
- Provide safety operational support and expertise to clinical trial study teams as needed, including attending Study Team Meetings and writing/reviewing Safety Management Plans with oversight from Safety Operations leadership.
- Collaborate with Data Management to resolve discrepancies identified between the safety and clinical databases via 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 related 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-PAC regulation, ICH guidelines, and safety submissions.
- Demonstrated success providing vendor oversight.
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Demonstrated safety project lead/management experience.
- Strong cross-functional collaboration experience.
- Oncology experience is strongly preferred.
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