Pratyusha Moganti

Medical reviewer of ICSRs, including reviewing overall medical cohesiveness, assessment of adverse event(s) expectedness, adding company causality and comprehending the company comment

• Addressing queries for cases from a medical perspective for Drug Safety Associates who are involved in processing ICSRs
• Experienced in MedDRA coding and providing medical inputs while assessing MedDRA coding of events
• Review due diligence queries as needed and raise additional medical queries for pertinent information in the case
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with regulatory timelines
• Training and mentoring

* Providing training to safety personnel on MedDRA coding of events

*Mentoring new physicians to ensure confident reviewing of ICSRs

• Well versed with International Drug Safety Regulations including ICH Guidelines on Safety and Efficacy, FDA Guidelines, CIOMS, GVP Modules/New EU PV legislation, MedDRA Coding, Expectedness
• Work with Drug Safety Associates/ Medical Reviewers to address process/quality issues and findings if any
• Participation in client product meetings, product-specific meetings, and product transition meetings, etc.

• Junior Consultant in Department of Critical care

• Junior Consultant in Department of Anaesthesia and Critical care

• Senior Resident in Department of Anaesthesia

• Senior Resident in Department of Anaesthesia