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 communications, or compliance deviations.
Follow-up & Reconciliation
- Oversee follow-up correspondence with ICSR reporters to obtain additional information in accordance with Sponsor SOPs and project requirements.
- Ensure completion of reconciliations with internal functions and licensing partners regarding exchanged ICSRs and safety information.
- Maintain oversight of required daily, weekly, monthly, or quarterly reconciliation activities and ensure identified discrepancies are appropriately addressed and documented.
Quality, Compliance & Inspection Readiness
- Maintain continuous oversight of quality and compliance across assigned operations.
- Support local literature searches, reconciliation activities, and applicable quality assurance processes.
- Ensure assigned compliance investigations for late submissions or other identified deviations are completed accurately and within required timelines.
- Perform or oversee root-cause investigations and follow-up activities when quality or compliance issues are identified.
- Support CAPA or other remediation activities, where applicable, and monitor actions through completion.
- Maintain operational readiness for Sponsor audits, regulatory inspections, internal quality reviews, and other compliance assessments.
- Ensure appropriate documentation and evidence are maintained to demonstrate process and project compliance.
Stakeholder Management & Collaboration
- Build effective working relationships with Sponsor representatives and internal and external stakeholders.
- Partner with Safety Operations, Quality, Compliance, Training, Regulatory, and other applicable functions to resolve operational issues.
- Communicate operational status, risks, dependencies, and mitigation actions clearly and promptly.
- Escalate significant risks or recurring issues to appropriate project and functional leadership.
Key Accountabilities / Performance Expectations
The Manager is expected to demonstrate effective oversight across the following areas:
- 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
Qualifications:
- Education: Bachelor's degree in Life Sciences or a related scientific/medical discipline, or equivalent relevant pharmacovigilance experience.
- A third language will be highly valued.
Experience:
- Minimum 5 years of relevant professional experience.
- Minimum 3 years of Pharmacovigilance experience.
- Previous experience coordinating, supervising, or leading operational teams is strongly preferred.
- Experience working in a Sponsor-facing and/or global pharmacovigilance environment is preferred.
Skills & Competencies:
- Strong understanding of global and local pharmacovigilance regulations and guidelines.
- Strong people leadership, coaching, performance management, and team-development capabilities.
- Demonstrated ability to monitor and manage operational KPIs, quality metrics, SLAs, compliance, and workload.
- Strong stakeholder-management and Sponsor-facing communication skills.
- Ability to identify operational risks, analyze performance trends, escalate appropriately, and drive remediation.
- Strong organizational, prioritization, and time-management skills.
- Excellent written and verbal communication skills.
- Ability to operate independently while effectively leading a team in a matrix environment.
- Proficiency in English and the specific local/regional language(s), as applicable.
- Experience with electronic safety/data management systems such as Argus or equivalent global safety databases.
Preferred Qualifications:
- Pharmacy, Chemical, Nursing or other third-level scientific/medical education.
- Experience working with global safety databases.
- Previous formal experience managing direct reports.
- Experience supporting Sponsor governance, audits, inspections, deviations, CAPAs, and operational performance reviews
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.