ICON is Hiring PV Associate/Sr PV Associate in Chennai location

Job Role: PV Associate/Sr PV Associate

Department: Drug Safety

Locations: India, Chennai
Type: Full time
Job Requisition ID: JR118067

Key Responsibilities-PV Associate:

• Review and process safety events for drugs and medical devices, both before and after they are marketed, ensuring compliance with project-specific procedures.
• Read abstracts and full articles to identify safety information about products, ensuring thorough literature review for both pre-marketed and post-marketed products.
• Generate data listings from the safety database, taking responsibility for the accuracy and completeness of the data.
• Follow up on adverse events in writing or by phone based on client requirements, ensuring timely and accurate reporting.
• Review and update safety tracking systems for accuracy and quality, assisting with the maintenance of comprehensive project files.
• Review clinical and diagnostic data for safety as part of case processing, ensuring detailed analysis and documentation.
• Develop and ensure consistency of the Safety Management Plan, creating specific processes to maintain project consistency and compliance.
• Help create post-marketing safety activities such as Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), and Periodic Benefit-Risk Evaluation Report (PBRER), ensuring thorough documentation and reporting.
• Assist the Qualified Person for Pharmacovigilance as needed, providing support and ensuring compliance with regulatory requirements.
• Communicate with investigational sites, reporters, and Sponsors about safety issues, ensuring clear and effective communication.
• Collaborate with the ICON Medical Monitor, project manager, and other departments, facilitating effective teamwork and project coordination.
• Assist with identifying out of scope activities with the Pharmacovigilance Project Lead, ensuring timely and accurate identification.
• Attend project team and Sponsor meetings, including presenting safety processes at kick-off and investigator meetings, ensuring clear understanding and implementation.
• Support the creation of aggregated safety reports by retrieving data and completing assigned tasks, ensuring thorough and accurate reporting.
• Help with data analysis for Data Monitoring Committee (DMC) reviews, ensuring detailed and accurate analysis.
• Maintain the safety database and ensure quality data entry, following established quality control processes.
• Support the creation and implementation of the Serious Adverse Event (SAE)/Adverse Event (AE) reconciliation plan, ensuring accurate reconciliation in accordance with project-specific guidelines.
• Assist Safety Scientists in detecting safety signals and managing risks, providing support for thorough analysis and documentation.
• Ensure plans align with client contracts and identify out of scope activities, proposing solutions for procedural and technical issues.
• Support audits and inspections for assigned projects, ensuring thorough preparation and compliance.
• Perform additional tasks as requested by management, including responding to medical information inquiries and processing adverse event reports and product complaints, ensuring comprehensive and accurate documentation.

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About ICON:

ICON is a leading Clinical Research Organisation committed to helping pharmaceutical companies bring new drugs and medical devices to market quickly and efficiently. We aim to be the top partner in drug development, driven by a mission to accelerate client projects and deliver innovative solutions.

Our team consists of some of the brightest and friendliest professionals in the industry, working in a collaborative and supportive environment. At ICON, we value talent and dedication, and we provide opportunities for growth and development. Join us, and be part of a company that is shaping the future of clinical research and drug development.

Disclaimer: We strongly advise against paying any third-party individuals or agencies who claim to offer job placements at our company. All job openings are filled based on merit through our official hiring channels. Protect yourself from fraud and ensure that your application is processed securely and fairly by only engaging directly with our official representatives.