Drug Safety Associate (PharmD)

Roles & Responsibilities
• Perform initial triage and validity assessment of adverse event reports and clinical trial safety data
• Manage end-to-end case processing activities in line with pharmacovigilance requirements
• Execute accurate medical coding using MedDRA and WHO-DD dictionaries
• Conduct duplicate checks, reconciliation, and quality control (QC) to ensure audit-ready safety data
• Ensure strict compliance with ICH-GCP guidelines, 21 CFR Part 11, and global PV regulations
• Apply clinical judgment to audit and validate safety data within the digital platform
• Collaborate with the technology team by providing subject matter expertise to maintain clinically accurate workflows
• Support continuous process improvement aligned with evolving regulatory expectations

Qualification
• Doctor of Pharmacy (PharmD)

Experience
• Freshers to 4 years of experience in Pharmacovigilance or Drug Safety
• Candidates without prior industry experience will be trained during the probationary period

Skills
• Strong theoretical knowledge of MedDRA coding, case validity assessment, and triage processes
• Sound understanding of Pharmacovigilance fundamentals and ICH-GCP guidelines
• High attention to detail and strong quality orientation
• Good analytical and problem-solving skills
• Proficiency in MS Excel and MS Word
• Ability to work accurately in a compliance-driven environment

About the Company
CoReason.ai is a fast-growing HealthTech company operating at the intersection of life sciences and technology. The company develops advanced analytical platforms that enable pharmaceutical companies and healthcare organizations to make precise, data-driven decisions. With a strong focus on innovation, compliance, and patient safety, CoReason.ai is building next-generation solutions that transform how safety and clinical data are managed.