Medical Job – Manager PSUR at Sun Pharma in Gurgaon | Apply
Looking for a rewarding medical job in pharmacovigilance? Sun Pharmaceutical Industries Ltd is hiring a Manager – PSUR in Gurgaon under its Global Pharmacovigilance (GPV) division. This opportunity is ideal for professionals seeking Sun Pharma careers, especially candidates searching for medical jobs in Gurgaon, including MBBS jobs and MD jobs in drug safety and regulatory reporting.
Job Details:
- Job Title: Manager – Pharmacovigilance – PSUR
- Location: Gurgaon – R&D
- Company: Sun Pharmaceutical Industries Ltd
- Business Unit: GPV
- Job Grade: G10
About the Company:
Sun Pharmaceutical Industries Ltd is one of India’s leading pharmaceutical companies with a strong global presence. Through its commitment to innovation, research, and regulatory excellence, Sun Pharma continues to expand its footprint in global pharmacovigilance and drug safety. Professionals exploring Sun Pharma careers benefit from a culture that encourages growth, collaboration, and continuous learning.
Job Description:
This medical job is for the position of Manager – Pharmacovigilance (PSUR) under the GPV Business Unit at Sun Pharma, Gurgaon – R&D. The role involves working on Periodic Safety Update Reports (PSUR), safety signal detection, regulatory documentation, and risk characterization for New Chemical Entities (NCEs) or Innovator Products.
This opportunity is ideal for candidates seeking medical jobs in Gurgaon, particularly professionals looking for a specialized MBBS Job or MD Job in pharmacovigilance.
Required Qualifications & Skills:
- MBBS or MD
- Proficient in causality assessment, MedDRA coding, and understanding regulatory document requirements, including DSUR, PSUR/PBRER, PADER, RMP, SMP, Clinical Study Protocols of New Chemical Entities (NCEs) or Innovator Products.
- Experience: 3-4 years
Key Responsibilities:
- Analyze individual case safety reports (ICSRs) within aggregate contexts, evaluating seriousness, expectedness, and causality.
- Integrate findings into cumulative safety profiles for New Chemical Entities (NCEs) or Innovator Products.
- Perform risk characterization.
- Review published scientific literature for PSUR.
- Prepare summary tabulations for PSUR.
- Prepare special situation case write-ups for PSUR.
- Interpret trends and emerging signals across datasets to assess and update the product’s benefit-risk balance.
- Work in Pharmacovigilance projects 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 a pharmacovigilance point of view.
- Review Safety Management Plans.
