Pharmacovigilance Associate

Roles & Responsibilities
• Support drug safety activities by collecting, processing, and documenting adverse event (AE) reports
• Perform case intake, data entry, and follow-up activities in pharmacovigilance safety databases
• Ensure accurate and timely processing of Individual Case Safety Reports (ICSRs)
• Maintain compliance with global regulatory guidelines such as ICH-GCP, FDA, and EMA
• Assist in preparation of safety reports, listings, and regulatory submissions
• Support signal detection and safety surveillance activities
• Collaborate with cross-functional teams to ensure patient safety and data quality
• Maintain proper documentation and audit readiness

Qualification
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline

Experience
• Fresher or up to 1 year of experience in Pharmacovigilance / Drug Safety
• Internship or academic exposure to PV activities is an added advantage

Skills
• Basic knowledge of pharmacovigilance and drug safety processes
• Familiarity with safety databases such as Argus, ArisG, or similar systems
• Strong attention to detail and documentation skills
• Good understanding of regulatory compliance requirements
• Effective written and verbal communication skills

About the Organization
Fusion Technology Solutions is a growing technology-driven organization supporting pharmaceutical and healthcare companies with regulatory, safety, and data-focused solutions, committed to maintaining high standards of patient safety and compliance.