Job Description
● Ensure that current registration requirements are available, communicated, and implemented both with Iran’s MOH and related foreign companies.
● Manage for preparation of all required documents such as guidelines, specifications, certificates, and reports for different departments.
● Prepare documents and dossiers for submission/registration dossiers to the medical evaluation board and supervise the registration procedure in order to obtain and maintain registration through interaction with health authorities.
● Interpret and implement quality assurance standards.
● Evaluate the adequacy of quality and preparation of all required SOPs and updating documents and collaborate with different departments and monitoring systems.
● Customer complaints and non-conformance issues.
● Collect and compile statistical quality data.
● Analyze data to identify areas for improvement in the quality system and development.
● Assist in the maintenance of the company's compliance with respect to laws, regulations, and guidance during different clinical trials and pharmacovigilance.
● Assure the proper implementation and observation of all safety-related Standard Operating Procedures (SOPs), collects, review, and assess the adverse event information regarding all therapeutic areas.
● Prepare and submit individual case safety reports to the local health authorities of Iran according to the local regulations.
● Contribute to local safety observation detection and review of relevant medical literature according to the PV standard operations and procedures.
● Ensure the pharmacovigilance process is implemented and followed.
● Continue reporting to the Head of the regulatory department.
