Key Responsibilities
• Process and triage Individual Case Safety Reports (ICSRs) as per SOPs and safety plans
• Perform case data entry, MedDRA coding, and narrative writing
• Conduct literature screening and safety reviews
• Identify, manage, and reconcile duplicate ICSRs
• Perform quality review of safety cases
• Support xEVMPD submissions and SPOR/IDMP activities
• Maintain safety trackers and ensure regulatory compliance (ICH GCP, GVP)
• Submit documents to TMF and PSMF
• Participate in audits and regulatory inspections
• Collaborate with global cross-functional PV teams
Education:
• B.Pharm / M.Pharm / Pharm.D / BDS
Experience
• Specialist I: 2+ years
Technical Skills:
• Strong knowledge of ICH, GVP, and global PV regulations
• Hands-on experience with safety databases
• Understanding of Clinical Trial phases II–IV and post-marketing safety
• Proficiency in MS Word, Excel, PowerPoint, Outlook
Soft Skills:
• Excellent communication and documentation skills
• Strong attention to detail and organizational ability
• Work on global studies involving 675,000+ clinical trial patients
• Exposure to global audits, inspections, and regulatory submissions
• Strong internal mobility and career development programs
• Inclusive Total Self culture promoting diversity and well-being
• Competitive compensation and rewards
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