Responsibilities:
Responsible for establishing and implementing the pharmacovigilance system for marketing authorization holder (MAH)/sponsor.
Maintaining and improving compliance.
Review and submit pharmacovigilance-related documents, including but not limited to PSUR/PBRER/DSUR.
Ensure the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to authorities.
Maintenance and improvement of the quality system in pharmacovigilance system (oversight over relevant aspects, e.g. SOPs, contractual arrangements, database, compliance and quality of expedited reporting, submission of periodic update reports, audit reports, training and so on).
Ensure a full and prompt response to any request from the authorities for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
Provide any other information relevant to the benefit-risk evaluation to the authorities.
Provide i...