Are you looking for Pharmacovigilance submission specialist jobs in Mumbai? A leading ITES company, hiring via Outpace Consulting Services, is actively recruiting PV Submission Specialists with experience in ICSR submissions, ARGUS database, and global regulatory compliance.
This is a strong opportunity for candidates with 1–4 years of pharmacovigilance experience who want to build expertise in global safety submissions, case processing, and regulatory workflows.
📌 Job Overview
The Pharmacovigilance Submission Specialist will be responsible for handling regulatory submissions of Individual Case Safety Reports (ICSRs) for both clinical trials and post-marketing surveillance. The role focuses on ensuring timely, accurate, and compliant submissions aligned with global health authority requirements.
🧪 Key Responsibilities
- Perform ICSR submissions for clinical trial and post-marketing cases
- Work on ARGUS safety database for case processing and submission workflows
- Review adverse event (AE) data and local labeling for submission accuracy
- Monitor and manage submission queues, including failed or pending cases
- Execute case corrections and distribution workflows
- Ensure compliance with global regulatory timelines (FDA, EMA, MHRA, etc.)
- Identify data gaps, inconsistencies, and quality issues
- Maintain submission tracking logs and documentation
- Follow internal SOPs, WRKs, MANs, and compliance frameworks
- Stay updated on pharmacovigilance regulations and submission standards
🎓 Qualifications & Skills
- B.Pharm / M.Pharm / Life Sciences Graduate
- Minimum 1 year experience in Pharmacovigilance submissions
- Hands-on experience with ARGUS database
- Knowledge of global safety reporting & ICSR submissions
- Strong understanding of medical terminology & clinical data
- Familiarity with case processing, QC, and regulatory compliance
- Good analytical, organizational, and communication skills
💼 Salary & Benefits
- 💰 Salary: ₹3,00,000 – ₹6,00,000 per annum (CTC)
- 📈 Career growth in global pharmacovigilance & drug safety domain
- 🌍 Exposure to international regulatory submissions
- 🧠 Skill development in ARGUS, ICSR workflows, and compliance systems
- 🏢 Opportunity to work with a leading ITES/CRO environment
📍 Job Details
- Role: Pharmacovigilance Submission Specialist
- Location: Mumbai (All Areas)
- Experience: 1–4 Years
- Openings: 17
- Employment Type: Full-Time, Permanent
🚀 How to Apply
