• Conduct thorough assessment and evaluation of adverse event data to determine causality, seriousness, and expectedness.
• Prepare and submit expedited and periodic safety reports to regulatory authorities within specified timelines.
• Collaborate cross-functionally with medical affairs, regulatory affairs, clinical development, and other relevant departments to ensure alignment on pharmacovigilance activities.
• Participate in the development and implementation of pharmacovigilance processes, standard operating procedures (SOPs), and training materials.
• Stay abreast of evolving pharmacovigilance regulations, guidelines, and industry best practices.
• Contribute to pharmacovigilance signal detection activities and risk management strategies.
• Participate in pharmacovigilance audits, inspections, and quality assurance activities as needed.
• Provide support and guidance to internal teams and external partners regarding pharmacovigilance-related queries and issues