Job description

Preparation and review of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc. Co-ordination with various stakeholders to gather data required for Aggregate reports. Work closely with service providers and resolve their queries. Co-ordinate with various stakeholders internal and external required for the completion reports. Preparation and review of Query responses from Regulatory Authority

Skills Required

Key Skills

• RMP
• PADERS
• PBRERS

Other Information