- *Medical assessment of the safety profile of the client's product range
*Responsibility for evaluation of Adverse Events
*Medical Review of aggregate reports
*Performing signal detection for client's medicinal product
*Preparation, evaluation and management of risk management plan.
*Preparing Clinical Expert Statements as per client requirement
*Literature review for selection of ICSR and article of interest (for signal detection and aggregate reports)
*Provide guidance and participation in the follow-up of Adverse Events
*Provide back-up medical support on products/projects where required
*Knowledge of local and national requirements for Pharmacovigilance requirements.
*Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.
*Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
*Ensuring compliance with local regulations and Company global Pharmacovigilance requirements.
*Providing medical inputs/replying any medical inquiry and to identify any potential AE in product quality complaint for all Lambda clients.
*Assist in the development of appropriate Standard Operating Procedures and for the Department and clients.
*Communication with clients and or regulatory agencies if required
Posts
