• Working as Lead consultant and project manager.• Authoring of aggregate reports, including PBRERs, DSURs, PADERs and six-monthly line listings.• Conducts literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.• Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked.• Creation of Process maps and SOPs required for the process.• Participate in internal and external audits, as required.

• Basic knowledge of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)• Contributes to small to medium aggregate reports, including but not limited to PBRERs, DSURs, PADERs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required. • Contributes in the conduct of ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. • Provide assistance in signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. • Participate in internal and external audits, as required. • Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. • Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented

Serious Case processing- from Triaging of a case till Processing of the case including narrative writing. (spontaneous, solicited, Clinical trial and literature reports).Literature screening.Good experience on Aris g and Argus databases.