Ocugen Inc Hiring For ICSR Submissions Specialist (Pharmacovigilance)

Ocugen Inc is hiring an experienced ICSR Submissions Specialist (Pharmacovigilance) for its Hyderabad location. This is an excellent opportunity for professionals with strong expertise in ICSR submissions, Argus Safety, and global pharmacovigilance compliance to work in a fast-growing biopharma environment.

If you have hands-on experience in E2B(R2/R3), FDA/EMA submissions, and global safety reporting, this role offers career growth in international drug safety operations.

📌 Job Details

• Role: ICSR Submissions Specialist (Pharmacovigilance)
• Location: Hyderabad, Telangana, India
• Job Type: Full-time, On-site
• Experience: 5+ Years (3+ years in ICSR submissions)
• Department: Drug Safety / Pharmacovigilance

🧩 Key Responsibilities

• Manage end-to-end ICSR submissions to global regulatory authorities (FDA, EMA, MHRA, PMDA, Health Canada)
• Ensure timely submission of expedited (7-day/15-day) and periodic safety reports
• Perform E2B (R2/R3) electronic submissions via regulatory gateways
• Monitor acknowledgements and resolve submission failures or technical issues
• Conduct quality checks on ICSRs for completeness and regulatory compliance
• Collaborate with Case Processing, QA, IT, and Regulatory Affairs teams
• Maintain submission logs, reconciliation records, and audit-ready documentation
• Support inspections, audits, and health authority queries
• Ensure compliance with ICH E2B, E2A, GVP, and 21 CFR regulations
• Drive process improvements and automation in safety reporting
• Train junior team members on ICSR submission processes and systems

🎓 Qualifications & Skills

• Education: B.Pharm / M.Pharm / PharmD / Life Sciences / Medicine
• Experience:
  • Minimum 5 years in Pharmacovigilance
  • At least 3 years in ICSR submissions
• Technical Skills:
  • Strong knowledge of ICH E2B (R2/R3)
  • Hands-on experience with Argus Safety (mandatory)
  • Experience with global regulatory submissions (US, EU, ROW)
  • Exposure to signal management & aggregate reporting
• Other Requirements:
  • Experience in CRO/pharmaceutical industry
  • Knowledge of partner safety data exchange agreements

💼 Benefits

• Opportunity to work with a global biopharmaceutical company
• Exposure to international pharmacovigilance systems and regulations
• Career growth in drug safety and regulatory compliance
• Collaborative work environment with cross-functional teams
• Competitive salary and performance-driven culture

📩 How to Apply

Application Link