Pharmacovigilance Analyst
IQVIA · Santiago
Key Responsibilities:
Provides high-quality, timely support to pharmacovigilance and lifecycle safety activities across client projects in LATAM. Responsibilities include adverse event identification, data source review, client reporting, quality oversight, regulatory compliance support, and contribution to safety-related project deliverables. Assignments may range from routine case/data review and issue identification to supporting process improvements, audits, RFPs, and client-specific safety solutions.
Essential Functions
- Reviews and analyzes project materials, data sources, questionnaires, reports, and other client documentation to identify potential adverse events, product quality complaints, special situations, or other safety-relevant information.
- Ensures timely and accurate reporting of adverse events to clients in accordance with contractual timelines, local requirements, and applicable pharmacovigilance standards.
- Supports the development and maintenance of pharmacovigilance documentation, trackers, project-specific procedures, training materials, and reporting specifications.
- Performs qualitative review of safety information to ensure completeness, accuracy, consistency, and compliance with agreed processes.
- Supports client deliverables related to pharmacovigilance, including AE reports, reconciliation outputs, audit responses, metrics, and safety process documentation.
- Collaborates with cross-functional teams, including PMR, CES, Consulting, Quality, Operations, and client teams, to ensure appropriate safety oversight across projects.
- Supports quality management activities, including QC checks, deviation identification, CAPA support, audit readiness, and implementation of process improvements.
- Contributes to RFP reviews, project start-up activities, and client discussions by providing pharmacovigilance and safety input.
- Maintains current knowledge of pharmacovigilance requirements, local LATAM regulations, GVP principles, and client-specific safety obligations.
- May provide training, coaching, and guidance to junior analysts on AE identification, reporting requirements, quality expectations, and safety processes.
Qualifications
- Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, Medicine, Biology, Chemistry, or related health/scientific field required.
- 2–4 years of related experience in Pharmacovigilance, Lifecycle Safety, Clinical Safety, Quality, Regulatory, or Life Sciences operations required.
- Strong understanding of adverse event identification, safety reporting timelines, pharmacovigilance concepts, and client reporting obligations.
- Knowledge of pharmacovigilance regulations, GVP principles, and local LATAM safety requirements preferred.
- Ability to review scientific, medical, and operational documentation with accuracy and attention to detail.
- Strong analytical, organizational, and time management skills, with ability to manage multiple projects and deadlines simultaneously.
- Effective communication skills and ability to work collaboratively with internal teams and external clients.
- Experience supporting audits, quality checks, CAPA activities, reconciliations, or process improvement initiatives is desirable.
- Ability to work effectively in a high-volume, compliance-driven environment where timely AE reporting is critical.
- Process Improvement: Identify opportunities for process improvements and implement best practices to enhance efficiency and effectiveness.
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.