Pharmacovigilance- PSUR & Aggregate

Sun Pharma; Gurugram District; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharma is seeking a Pharmacovigilance professional to analyze individual case safety reports and synthesize findings for NCEs or innovator products. You will contribute to safety profiles by evaluating seriousness, causality, and regulatory requirements.

The role involves risk characterization, literature review for PSUR, and preparation of PSUR summaries. You will participate in PV projects, assess emerging safety signals, and review clinical study protocols from PV perspective.

Qualifications

• Proficiency in causality assessment and MedDRA coding.
• Experience with PSUR/DSUR/PBRER/PADER regulatory documents.
• Understanding of regulatory requirements for NCEs or innovator products.

Responsibilities

• Analyze ICSRs within aggregate contexts and evaluate seriousness, causality, and expectedness.
• Prepare PSUR summaries and trend analyses to update benefit-risk balance.
• Review literature for PSUR and prepare safety issue write-ups for PSUR interpretation.
• Collaborate on PV projects, including responses to agency assessment reports.
• Evaluate safety notifications to qualify ESIs/SSIs and review Safety Management Plans.

Skills

Causality assessment

MedDRA coding

Regulatory documentation

Education

MBBS or MD

Job description

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.