Associate, Pharmacovigilance

Hikma Quality

Duties & Responsibilities:

• Follows all relevant Department policies, processes, standard operating procedures, and instructions so that work is carried out in a controlled and consistent manner.
• Monitors regulations and guidelines to detect PV updates.
• Assists in the performance of PV activities in Egypt, including but not limited to, case processing, local literature searching, aggregate reporting, risk management, health risk assessment, product labeling reviews, and safety agreements, to ensure compliance with procedural and regulatory requirements.
• Prepares PV documents in Egypt, including but not limited to, aggregate reports, risk management plans, health risk assessments, and safety agreements to ensure submission within the required timelines.
• Assists in the implementation and evaluation of the effectiveness of RMP-related activities in Egypt to ensure compliance with commitments made to regulatory authorities.
• Assists in the creation and update of local PV procedures, and National PSSF(s) for Egypt to ensure alignment with global procedures and regulatory requirements.
• Assists in the safety review of clinical study protocols, data management plans, statistical analysis reports, interim reports, and clinical study reports (CSRs) for studies in Egypt.
• Aids in the updates of the global product database to ensure it contains reliable and up to date product information for Egypt products.
• Contributes to the identification of opportunities for continuous improvement of systems, processes and practices considering industry best practices, improvement of business processes, cost reduction and productivity improvement.
• Assists in the preparation of timely and accurate reports to meet company and Department requirements, policies, and standards.