Description
The Safety Operations Team Assoc. Manager is responsible for leading and overseeing local and/or regional pharmacovigilance operations, ensuring effective delivery of safety activities in accordance with applicable regulations, Sponsor requirements, project procedures, SOPs, quality standards, and agreed KPIs/SLAs.
The role provides direct leadership and oversight of assigned team members, with accountability for team performance, workload management, operational quality, compliance, capability development, and timely delivery.
Key Responsibilities:
- People Management & Direct Report Oversight: Provide day-to-day leadership, supervision, and operational oversight of assigned direct reports. Set clear expectations regarding productivity, quality, compliance, timelines, and professional behaviors.
- Sponsor, Project & KPI Management: Serve as a primary operational point of contact for the Sponsor, when applicable, supporting effective communication and alignment on project deliverables.
- Pharmacovigilance Operations Oversight: Lead and oversee safety-related operations and communication activities.
- Mailbox Screening & Case Intake: Oversee the monitoring of regional and global adverse-event mailboxes across applicable languages and Customer Affiliates.
- Follow-up & Reconciliation: Oversee follow-up correspondence with ICSR reporters to obtain additional information in accordance with Sponsor SOPs and project requirements.
- Quality, Compliance & Inspection Readiness: Maintain continuous oversight of quality and compliance across assigned operations.
- Stakeholder Management & Collaboration: Build effective working relationships with Sponsor representatives and internal and external stakeholders.
Key Accountabilities / Performance Expectations
- Sponsor KPI/SLA compliance
- Timeliness of safety activities and submissions
- ICSR processing quality and compliance
- Mailbox and intake timeliness
- Reconciliation completion and discrepancy management
- Team productivity and workload management
- Training and qualification compliance
- Quality-event/deviation management
- CAPA and remediation follow-up, where applicable
- Audit and inspection readiness
- Direct-report performance and development
- Sponsor satisfaction and effective stakeholder communication
- Operational risk identification and timely escalation