PV ? Medical writing _Deputy Manager/ Assistant Manager

MumbaiFull Time
RMP PADERS PBRERS
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
PV ? Medical writing _Deputy Manager/ Assistant Manager
Pharma
Pharmaceutical
Full Time, Permanent
Life Sciences and Pharma
Key Skills
  • RMP
  • PADERS
  • PBRERS
Other Information
GO/JC/20089/2024
HariharanA

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