Manager, Patient Safety and PV Operations - Contractor in US
Arcus Biosciences
June 26, 2026
Remote friendly (United States)
United States
Operations
Responsibilities:
- Support vendor management and oversight of end-to-end safety case processing and safety reporting activities performed by an external safety vendor and CROs.
- Review vendor project plans; provide guidance and safety operational subject-matter expertise.
- Monitor vendor deliverables/action items to ensure timeline compliance.
- Ensure on-time submission of expedited and aggregate safety reports via effective vendor management and performance metric reviews.
- Perform retrospective quality control of safety cases to maintain safety case and submission quality.
- Oversee safety database (Argus) updates and configuration needs (MedDRA/WHO Drug updates, study configurations, safety gateway expedited submissions, site query management).
- Support safety data exchange oversight in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements.
Cross-Functional Support:
- Provide safety operational support to study teams (attend study team meetings; write/review Safety Management Plans with Safety Operations leadership oversight).
- Collaborate with Data Management on SAE reconciliation to resolve safety/clinical database discrepancies.
- Partner with Safety Quality and Compliance for inspection readiness; support audits and global regulatory inspections.
- Escalate safety noncompliance issues/trends and support investigations and CAPAs.
- Support global filing activities for product approval as needed; collaborate on SDEAs/PVAs.
Qualifications:
- Bachelor’s degree in nursing, pharmacy, or other health care-related field.
- 4+ years’ experience in Clinical Safety Operations.
- Strong knowledge/experience with Argus, document management systems, QC tools, and MedDRA.
- Strong knowledge of FDA, EMA, MHRA, Asia-PAC regulations, ICH guidelines, and safety submissions.
- Demonstrated success in vendor oversight and safety project lead/management.
- Excellent interpersonal, communication, analytical, and organizational skills; strong cross-functional collaboration.
- Oncology experience strongly preferred.
- Support vendor management and oversight of end-to-end safety case processing and safety reporting activities performed by an external safety vendor and CROs.
- Review vendor project plans; provide guidance and safety operational subject-matter expertise.
- Monitor vendor deliverables/action items to ensure timeline compliance.
- Ensure on-time submission of expedited and aggregate safety reports via effective vendor management and performance metric reviews.
- Perform retrospective quality control of safety cases to maintain safety case and submission quality.
- Oversee safety database (Argus) updates and configuration needs (MedDRA/WHO Drug updates, study configurations, safety gateway expedited submissions, site query management).
- Support safety data exchange oversight in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements.
Cross-Functional Support:
- Provide safety operational support to study teams (attend study team meetings; write/review Safety Management Plans with Safety Operations leadership oversight).
- Collaborate with Data Management on SAE reconciliation to resolve safety/clinical database discrepancies.
- Partner with Safety Quality and Compliance for inspection readiness; support audits and global regulatory inspections.
- Escalate safety noncompliance issues/trends and support investigations and CAPAs.
- Support global filing activities for product approval as needed; collaborate on SDEAs/PVAs.
Qualifications:
- Bachelor’s degree in nursing, pharmacy, or other health care-related field.
- 4+ years’ experience in Clinical Safety Operations.
- Strong knowledge/experience with Argus, document management systems, QC tools, and MedDRA.
- Strong knowledge of FDA, EMA, MHRA, Asia-PAC regulations, ICH guidelines, and safety submissions.
- Demonstrated success in vendor oversight and safety project lead/management.
- Excellent interpersonal, communication, analytical, and organizational skills; strong cross-functional collaboration.
- Oncology experience strongly preferred.