Job overview
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. The Manager also serves as a key operational contact for the Sponsor and project stakeholders, proactively monitoring performance against project KPIs, identifying risks and trends, and driving corrective or preventive actions when performance deviates from expectations.
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.
Monitor individual and team performance against defined project requirements and operational KPIs.
Conduct regular one-to-one discussions, coaching, feedback, and performance conversations with direct reports.
Support employee development, training completion, competency building, and career development.
Ensure adequate onboarding and role-specific training before team members independently perform assigned activities.
Monitor team capacity, workload distribution, utilization, coverage, and operational priorities to maintain business continuity.
Identify performance or compliance gaps and establish appropriate improvement and follow-up actions.
Promote accountability, collaboration, engagement, and a strong quality and compliance culture across the team.
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.
Maintain oversight of contractual and project-specific KPIs, SLAs, quality metrics, productivity expectations, and compliance requirements.
Regularly review operational performance and identify emerging trends, risks, capacity constraints, backlogs, or potential KPI deviations.
Ensure appropriate and timely escalation of risks or issues that may affect Sponsor commitments, patient safety, regulatory compliance, quality, or project performance.
Coordinate and monitor remediation activities for KPI or compliance deviations, including corrective and preventive measures as applicable.
Support project governance meetings, operational reviews, performance reporting, and Sponsor discussions.
Drive continuous improvement initiatives to strengthen operational efficiency, quality, compliance, and service delivery.
Pharmacovigilance Operations Oversight:
Lead and oversee safety-related operations and communication activities.
Ensure accurate and timely ICSR surveillance, including collection, intake, reporting, follow-up, and associated documentation.
Oversee translation activities and local case narrative preparation where required.
Ensure activities are conducted in accordance with applicable global and local pharmacovigilance regulations, Sponsor procedures, project requirements, and SOPs
Maintain appropriate operational controls to ensure timely identification and escalation of safety information.
Mailbox Screening & Case Intake
Oversee the monitoring of regional and global adverse-event mailboxes across applicable languages and Customer Affiliates, including South Korea.
Ensure received communications are assessed and appropriately actioned within the required 1-business-day timeframe.
Ensure accurate creation of Case Reports for serious and non-serious adverse events, including initial and follow-up reports, for entry into the Global Safety Database.
Monitor workload and coverage to reduce the risk of late processing, missed…