PV Aggregate Reporting - GO/JC/756/2025

0 years

0 Lacs

Posted:3 weeks ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

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

RolePV Aggregate ReportingIndustry TypePharmaceuticalsFunctional AreaRequired Education Bachelor, Bachelor DegreeEmployment TypeFull Time, PermanentKey Skills
  • PSUR
  • DSUR
  • PV
  • AGGREGATE
  • SIGNAL
Other Information
Job CodeGO/JC/756/2025Recruiter NameSangeetha Tamil

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