Title:  Pharmacovigilance Officer - Tamheer Program

• Follows all relevant Department policies, processes, standard operating procedures, and instructions so that work is carried out in a controlled and consistent manner.
• Follows the day-to-day operations related to own job to ensure continuity of work.
• Assists in monitoring regulations and guidelines to detect PV updates.
• Assists in the performance of PV activities in Saudi Arabia and the rest of the GCC, 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 Saudi Arabia and the rest of the GCC, 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 Saudi Arabia and the rest of the GCC to ensure compliance with commitments made to regulatory authorities.
• Assists in the creation and update of local PV procedures, and National PSSF(s) for Saudi Arabia and the rest of the GCC 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 Saudi Arabia and the rest of the GCC.
• 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.
• Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment.
• Performs other related duties or assignments as directed.

Minimum Qualifications:

• Bachelor’s degree in MD, PharmD or Pharmacy.
• Fresh graduated
• Not registered in GOSI in last 6 months
• Saudi nationality