Clinical Data and Pharmacovigilance AssociateAbout the Company: IGC Pharma SAS is based in Bogota and is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company that focuses on preventing and managing Alzheimer's and other CNS diseases. We are committed to finding effective treatments through clinical research.
We are seeking a highly skilled Clinical Data and Pharmacovigilance Associate (Junior Level) to join our team to support and guide the cognitive assessment components of our clinical trials.
Job Description:We are seeking a detail-oriented and motivated Clinical Data and Pharmacovigilance Associate to support the collection, management, and analysis of clinical data, as well as the monitoring of safety data from clinical trials. This position is ideal for individuals at the start of their careers who are eager to grow in clinical research and pharmacovigilance.
Key Responsibilities:Perform accurate and timely data entry into electronic data capture systems (EDC).Validate and clean data to ensure consistency, accuracy, and completeness.Generate and review data reports to support trial progress.Assist in the development and maintenance of data management plans and standard operating procedures (SOPs).Monitor and record adverse drug reactions (ADRs) and safety events during clinical trials.Assist in preparing and submitting pharmacovigilance reports to regulatory authorities.Maintain and update pharmacovigilance databases in compliance with Good Pharmacovigilance Practices (GVP).Collaborate with the clinical team to ensure timely resolution of safety queries.Ensure compliance with regulatory guidelines, including ICH-GCP and local regulations.Participate in team meetings and provide updates on assigned tasks.Support audits and inspections by maintaining accurate documentation and records.Qualifications:Bachelor's degree in health sciences, Pharmacy, Nursing, or related field.0-2 years of experience in clinical research, pharmacovigilance, or related areas.Internship or academic projects in clinical research or pharmacovigilance are a plus.Skills:Strong attention to detail and organizational skills.Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).Basic understanding of regulatory guidelines (ICH-GCP, GVP) is preferred.Good written and verbal communication skills in English.Ability to work collaboratively in a team environment.Strong analytical and problem-solving skills.Eagerness to learn and adapt to new challenges.About IGC Pharma SAS:We are an exciting, young, diverse workplace with excellent benefits, including travel to the U.S., training, competitive salary, and a purpose-driven culture. This position is based in Bogota.
Application Process:Interested candidates should submit their CV, cover letter, and any relevant clinical trial experience. Please include any publications or research contributions in Alzheimer's disease or neurodegenerative disorders.
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