Job Description
Roles & Responsibilities
Monitors regulations and guidelines to detect PV updates.
Assists in the performance of PV activities in Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen), including but not limited to, case management, 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 Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen), 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 Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen) to ensure compliance with commitments made to regulatory authorities.
Assists in the creation and update of local PV procedures, and National PSSF(s) for Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen) 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 Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen).
Aids in the updates of the global product database to ensure it contains reliable and up to date product information for Levant (i.e., Iraq, Lebanon, Syria, Sudan, Libya, and Yemen) products.
Good English (written and spoken)
Proficiency in Microsoft Excel and Word
Good communication and interpersonal skills
Flexibility and adaptability
Attention to detail
Good organizational and time management skills
Willingness to learn
Team player with a positive attitude