Pharmacovigilance- PSUR & Aggregate

Role & responsibilities

• Analyze individual case safety reports (ICSRs) within aggregate contexts, evaluating seriousness, expectedness, causality and integrate findings into cumulative safety profiles for New Chemical Entities (NCEs) or Innovator Products.
• Risk Characterization
• Review of published scientific literature for PSUR
• Preparation of Summary tabulation for PSUR
• Preparation of special situation cases write up for PSUR Interpret trends and emerging signals across datasets to assess and update the products benefit-risk balance
• Work in Pharmacovigilance projects as assigned such as collation of response to assessment reports received from the agency
• Perform Evaluation of Safety Notifications to qualify Emerging Safety Issues (ESIs) / Significant Safety Issues (SSIs)
• Review Clinical Trial Protocols for NCEs or Innovator Products from PV point of view
• Review Safety Management Plans.

Preferred candidate profile

• MBBS or MD
• Proficient in causality assessment, Med DRA coding, and understanding regulatory document requirements, including DSUR, PSUR/PBRER, PADER, RMP, SMP, Clinical Study Protocols of New Chemical Entities (NCEs) or Innovator Products.