dverse Event Reporting: o Collect, evaluate, and report adverse events (AEs) from healthcare professionals, patients, or other sources. o Ensure timely submission of pharmacovigilance reports to regulatory bodies (e.g., FDA, EMA). o Maintain a Pharmacovigilance System Master File (PSMF) if required by regulations. 2. Risk Management: o Develop and implement Risk Management Plans (RMPs) for marketed products. o Analyze risk-benefit profiles and provide recommendations to management and regulatory authorities. 3. Compliance with Regulations: o Ensure compliance with local and international pharmacovigilance regulations and guidelines (e.g., ICH E2E, GVP, FDA regulations). o Stay updated on global pharmacovigilance regulations and industry best practices. 4. Signal Detection & Risk Evaluation: o Analyze adverse event data to detect new safety signals. o Conduct benefit-risk assessments and communicate findings to stakeholders. 5. Safety Data Management: o Ensure accurate data collection, storage, and reporting of safety information. o Use pharmacovigilance databases (e.g., ARGUS, Veeva Vault QMS, or similar systems) for managing safety data. 6. Collaboration & Communication: o Collaborate with medical affairs, regulatory affairs, and clinical development teams to ensure integrated safety management. o Communicate safety issues clearly to internal teams, health authorities, and healthcare providers. 7. Training and Awareness: o Train other employees (e.g., medical teams, sales representatives) on pharmacovigilance processes and reporting mechanisms. 8. Audits & Inspections: o Prepare for regulatory audits and inspections related to pharmacovigilance. o Ensure that the pharmacovigilance system is continuously audited for compliance.

1. Education: • Minimum Requirement: A Bachelor's degree in Pharmacy, Medicine, or a related scientific field. • Preferred: A Master’s degree or Ph.D. in a relevant discipline (e.g., Pharmacology, Toxicology, Pharmaceutical Sciences). • Additional qualifications or certifications in Pharmacovigilance or Drug Safety (e.g., Drug Safety Associate Certification, ICH-GCP). 2. Experience: • Junior/Entry-Level (Pharmacovigilance Specialist): o 0-3 years of experience in pharmacovigilance or a related field (e.g., clinical research, regulatory affairs). o Familiarity with adverse event reporting systems and databases. 3. Key Competencies: • Knowledge of Pharmacovigilance Regulations: Familiarity with global pharmacovigilance guidelines such as ICH E2E, Good Pharmacovigilance Practices (GVP), and local regulatory requirements. • Data Analysis Skills: Proficiency in signal detection, trend analysis, and statistical analysis related to drug safety.