Entry Level Pharmacovigilance Associate

Entry Level Pharmacovigilance Associate Company: Lambda Therapeutic Research Ltd. Location: Ahmedabad, Gujarat, India Department: Pharmacovigilance Global Delivery Center Job Type: Full-Time Work Mode: Office-Based Shift: EU Shift (1:00 PM 10:00 PM) JOB OVERVIEW The Entry Level Pharmacovigilance Associate is responsible for supporting global drug safety operations by processing adverse event reports, managing Individual Case Safety Reports (ICSRs), maintaining pharmacovigilance databases, and ensuring compliance with global regulatory requirements and Good Pharmacovigilance Practices (GVP). This role provides hands-on exposure to global safety operations through structured training and professional development while contributing to accurate, timely, and high-quality safety reporting. KEY RESPONSIBILITIES ICSR Case Processing Receive, review, and process Individual Case Safety Reports (ICSRs). Validate safety cases according to regulatory requirements. Perform case data entry into pharmacovigilance databases. Ensure timely completion of assigned safety cases. Maintain case quality and accuracy throughout processing. Adverse Event Management Collect and evaluate adverse event reports. Support adverse drug reaction (ADR) reporting activities. Review source documents for reportable safety information. Identify missing information and initiate follow-up when required. Maintain accurate documentation of adverse events. Safety Database Management Enter and update safety information in global safety databases. Maintain accurate and complete pharmacovigilance records. Ensure data consistency and integrity. Perform quality checks on entered data. Support database maintenance activities. Regulatory Compliance Follow Good Pharmacovigilance Practices (GVP). Comply with global pharmacovigilance regulations and SOPs. Maintain confidentiality of safety information. Support inspection-ready documentation. Adhere to regulatory reporting timelines. Quality Assurance Perform self-quality checks on processed cases. Maintain high standards of data accuracy. Identify and correct data discrepancies. Follow established quality procedures. Support continuous quality improvement initiatives. Training & Professional Development Participate in structured pharmacovigilance training programs. Develop knowledge of global drug safety regulations. Learn pharmacovigilance systems and workflows. Build expertise in safety reporting processes. Contribute to continuous learning initiatives. EDUCATIONAL QUALIFICATIONS Required Bachelor of Pharmacy (B.Pharm) Master of Pharmacy (M.Pharm) Doctor of Pharmacy (Pharm.D) Bachelor of Dental Surgery (BDS) Master of Dental Surgery (MDS) EXPERIENCE REQUIREMENTS Required Freshers and early-career professionals are encouraged to apply. Preferred Basic understanding of Pharmacovigilance and Drug Safety Strong written and verbal communication skills Willingness to learn and work in a global environment .