We are seeking an initiative-taking and experienced senior associate to support and lead key aspects of Global Market Vigilance (GMV) operations. This role is instrumental in ensuring regulatory compliance and consumer safety through robust post-market surveillance. The ideal candi will bring hands-on expertise working in Pharmacovigilance databases like Veeva Vault Safety, a strong understanding of global AE reporting standards, and the ability to drive process improvements and cross-functional collaboration.
Key Responsibilities
Case Management & Compliance
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Lead the intake, triage, and documentation of adverse event (AE) complaints using Veeva Vault Safety.
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Perform advanced case assessments, including causality and seriousness evaluations.
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Ensure timely escalation of potential serious adverse events (SAEs) and support regulatory reporting.
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Oversee duplicate checks and data quality reviews to ensure accuracy and consistency.
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Ensure compliance with global AE reporting requirements and internal SOPs.
System & Process Optimization
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Support configuration, testing, and validation of safety database up and enhancements.
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Identify and implement process improvements to enhance efficiency and data integrity.
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Lead periodic audits and reconciliations of safety data with internal and external stakeholders.
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Maintain documentation and ensure audit readiness of safety records.
Cross-functional Collaboration & Leadership
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Function as a point of contact for internal teams (Regulatory Affairs, Quality Assurance, R&D) and external partners (Call Centers, Customer Experience Centers).
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Lead cross-functional meetings to align safety data, trends, and reporting strategies.
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Mentor and support junior team members in case processing and system use.
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Track and manage corrective and preventive actions (CAPAs) related to safety operations.
Reporting & Insights
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Generate and review safety reports, dashboards, and metrics for internal stakeholders.
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Contribute to the preparation of regulatory submissions and safety summaries.
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Analyze trends in AE data and provide insights to support product safety evaluations.
Continuous Improvement & Strategic Support
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Drive continuous improvement initiatives within GMV processes and systems.
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Support training initiatives and knowledge sharing across the team.
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Demonstrate flexibility and readiness to take on additional responsibilities as assigned by management.
Qualifications
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Bachelor s or Master s degree in Life Sciences, Pharmacy, or a related field.
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2-5 years of experience in Pharmacovigilance or Market Vigilance, preferably in consumer healthcare or cosmetics.
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Strong hands-on experience working with a Pharmacovigilance database like Veeva Vault Safety is required.
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Proficiency in MedDRA coding and global AE reporting standards (e.g., MedWatch, CIOMS).
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Experience with safety data analytics and generating metric and trending reports.
Key Attributes
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Proven ability to work independently and oversee cross-functional activities.
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Excellent communication and stakeholder management abilities. High diligence and commitment to quality.
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Strong analytical and critical thinking skills.
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Passion for consumer safety and continuous improvement.
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Eagerness to learn and grow within the regulatory and safety domain.