Preparing PSRs including Periodic Safety Update Reports(PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACO) and Semi-Annual Safety Reports in accordance with Client requirements/conventions and Standard Operating Procedures (SOPs).
Performing qualtiy check of PSRs as per client requirements.
Maintaining excellent knowledge of the safety profile of the assigned products, clients procedures and international drug safety regulations.
Maintaining an awareness to global regulatory requirements and reporting obligations and organizing wokload to ensure compliance with the timelines communicated by the client.
Interacting with internal or external contacts to resolve issues related to the processing of PSRs.
Identifying areas of concern within team and raising the issues with the Project Manager.
Mentoring new team members on the PSR process, as applicable.