Pharmacovigilance Analyst

Description

Position Summary: We are seeking a Pharmacovigilance Analyst to ensure regulatory compliance in drug safety, managing adverse events and the pharmacovigilance system. Key Highlights: 1. Opportunity for professional growth within a high-standard pharmaceutical company 2. Active participation in protecting patient safety 3. Collaborative, ethical, and quality-oriented work environment San Isidro, Peru \| Full time \| Office\-based \| R1548607 Join us on our exciting journey! IQVIA ™ is The Human Data Science Company ™, focused on leveraging data and science to help healthcare customers find better solutions for their patients. Formed from the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in information, technology, analytics, and human ingenuity to advance healthcare. We are currently seeking professionals interested in joining a major project with an important business partner. **Pharmacovigilance Analyst** --------------------------------- **Location:** Peru **Area:** Pharmacovigilance / Drug Safety **Industry:** Pharmaceutical We are seeking a **Pharmacovigilance Analyst** to ensure compliance with local and corporate regulatory requirements related to drug safety. The role will be responsible for executing pharmacovigilance activities across the product lifecycle, ensuring timely detection, assessment, follow-up, and reporting of adverse events, aligned with applicable regulations and quality standards. **Key Responsibilities** --------------------------------- ### **Safety Report Management** * Receive, assess, document, and report **adverse events** and **safety-related quality complaints**, in accordance with local and corporate regulatory timelines. * Conduct case follow\-up and ensure integrity and quality of reported information. * Manage Individual Case Safety Reports (ICSRs) in assigned pharmacovigilance systems. ### **Regulatory Compliance** * Ensure compliance with current Peruvian pharmacovigilance regulations and corporate guidelines. * Prepare, review, and submit regulatory reports such as **PSUR/PBRER**, local safety reports, and responses to health authorities. * Maintain up\-to\-date documentation of the Pharmacovigilance System. ### **Pharmacovigilance System Management** * Support implementation and maintenance of the **local Pharmacovigilance System**. * Participate in managing **deviations, CAPAs, and change controls** related to pharmacovigilance. * Collaborate in audit and regulatory inspection processes. ### **Stakeholder Management** * Serve as technical support on safety matters for internal departments (Quality, Regulatory Affairs, Medical, Marketing, Sales). * Coordinate with distributors and third parties to ensure compliance with safety reporting obligations. * Deliver internal and external pharmacovigilance training as required. **Required Profile** -------------------- ### **Academic Qualifications** * Professional in **Pharmaceutical Chemistry** ### **Experience** * Minimum **1–2 years of pharmacovigilance experience** within the pharmaceutical industry or related organizations. * Experience handling adverse event reports and regulatory compliance (desirable). ### **Technical Knowledge** * Peruvian pharmacovigilance legislation and international guidelines (ICH, GVP). * Safety report management (ICSRs). * Global or local pharmacovigilance systems. * Good Pharmacovigilance Practices (GVP). **Key Competencies** ---------------------- * **Attention to detail** and strong sense of responsibility. * Ability for **clinical analysis and evaluation**. * **Effective written and verbal communication**. * Organization and management of multiple cases and regulatory deadlines. * Collaborative work and compliance focus. * Adaptability to regulatory changes and global processes. ### **What We Offer** * Opportunity for professional growth within a high-standard pharmaceutical company. * Active participation in protecting patient safety. * Collaborative, ethical, and quality-oriented work environment. \#LI\-CES 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.