DIRECTOR OF DRUG SAFETY: Job Code C-02
RESPONSIBILITIES:
MISSION STATEMENT:
The Director is responsible for all activities related to the monitoring and reporting of the safety profile of marketed products on an ongoing basis. This includes the management of potential risks associated with these products, ensuring compliance with FDA regulations on expedited and periodic reporting of Adverse Events, developing and adhering to Corporate Standard Operating Procedures (SOP).
Ensures the accurate, comprehensive and reliable collection, documentation and follow-up of any reported post-marketing adverse experience according to guidance from the FDA.
Ensures the timely reporting of expedite and periodic reports to the FDA according to FDA regulations.
Prepares and approves the specific local SOPs intended to achieve the above duty, their update, their dissemination within the local organization and the training of relevant personnel.
Prepares and approves the specific local SOPs intended to ensure the total compliance of the Product Safety department.
QUALIFICATIONS:
• MD is required.
• Documented experience of safety monitoring of marketed products
• Detailed knowledge of FDA and other major international regulations and guidelines related to adverse event reporting
• Minimum 5 years of Drug Safety experience
• Proven records of successful management of a team

MANAGER DRUG SAFETY: Job Code C-03
Manage the processes and reporting of adverse events (AE) of marketed products and products under development while assuring compliance with regulatory requirements and internal SOP’S. Responsibilities also include the management and oversight of Drug Safety Associates and their roles for adverse event report processing, Periodic Reports, registry functions, case report documentation triage of individual case reports. Participate in the update and reconciliation adverse event case reports in the ARISg safety database system as required.
QUALIFICATIONS/EXPERIENCE: Minimum of a Bachelor of Science degree in life sciences and a minimum of 4-7 years experience in drug safety. Detailed knowledge of FDA & legal regulations and practices, and database management. Ability to effectively communicate with employees, consumers, and health professionals of varying levels of medical knowledge required. Good organizational skills, combined with an ability to follow projects to completion.