Safety Physician - Lead
Location: Noida
• Experience: Senior Level
• Openings: 1
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.
Must have Skill Set
PSUR
ICSR
Aggregate report
Safety Physician
Medical Review
Signal Detection