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A leading ITES company, hiring through Outpace Consulting Services, is inviting applications for the role of Pharmacovigilance Submission Specialist in Mumbai. This opportunity is ideal for B.Pharm / M.Pharm graduates with hands-on experience in pharmacovigilance submissions, ICSR processing, and ARGUS safety database.
With increasing global regulatory focus on drug safety, pharmacovigilance submission specialist jobs in Mumbai are in high demand. This role offers excellent exposure to global safety reporting, clinical trial and post-marketing submissions, and compliance with international health authorities.
Key Responsibilities – Pharmacovigilance Submission Specialist
- Manage and execute ICSR regulatory submissions for clinical trials and post-marketing products
- Perform global safety submissions to health authorities within regulatory timelines
- Handle case processing and submissions in ARGUS
- Review adverse event (AE) data and local labeling for accurate submission scheduling
- Monitor submission workflows and resolve pending or failed submissions
- Perform major corrections and complete case distribution in safety workflows
- Ensure compliance with global PV regulations, SOPs, WRKs, MANs, and BEDs
- Maintain accurate submission tracking and documentation
- Identify data gaps, quality issues, and provide feedback to stakeholders
- Stay updated with changes in pharmacovigilance regulations and submission standards
Eligibility & Qualifications
- Education: B.Pharm or M.Pharm
- Experience: 1–4 years in Pharmacovigilance (PV) Submission
- Proven experience in:
- ARGUS Safety database
- ICSR case processing and submissions
- Global regulatory reporting
- Strong understanding of:
- Medical terminology and clinical interpretation
- Quality control principles in PV
- Complex medical and safety data structures
- Excellent interpersonal, decision-making, and organizational skills
Salary & Benefits
- Salary Range: ₹3,00,000 – ₹6,00,000 per annum
- Work with a leading ITES organization
- Exposure to global pharmacovigilance submissions
- Career growth in drug safety and regulatory compliance
- Structured processes and compliance-driven environment
Job Location
📍 Mumbai (All Areas), Maharashtra
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How to Apply
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