Are you an experienced Pharmacovigilance (PV) professional ready to level up? A reputed organization is hiring PV Submission Specialists with hands-on expertise in post-marketing ICSR submissions and global safety reporting. If you’ve worked with international health authorities and thrive in compliance-driven environments, this role is calling.
📍 Job Locations
Openings across India’s key pharma hubs:
- Mumbai
- Pune
- Nagpur
- Bangalore
Apply for your preferred location or indicate flexibility.
🧪 Position
PV Submission Specialist
🔍 Experience Required
2–8 years of relevant Pharmacovigilance experience
Ideal for mid-level to senior professionals with exposure to global safety submissions.
📝 Key Skills & Expertise
- Post-marketing ICSR submissions
- Clinical trial safety submissions
- Global submission processes & timelines
- Submissions to global health authorities
- Strong command of PV regulations & compliance
🔧 Key Responsibilities
📤 ICSR & Safety Submissions
- Execute clinical trial and post-marketing ICSR submissions
- Support global/regional submissions within regulatory timelines
- Ensure accuracy, completeness, and compliance
📊 Submission Tracking & Monitoring
- Maintain submission records across projects
- Track status, ensure documentation integrity, stay audit-ready
🔍 Quality Review & Compliance
- Review safety data; flag gaps or omissions
- Coordinate with stakeholders to resolve issues pre-deadline
📚 SOP & Process Adherence
- Work per SOPs, WRKs, MANs, and BEDs
- Stay current with internal updates and global PV regulations
- Contribute to workflow improvements
🌍 Why This Role Matters
- Timely reporting to global health authorities 🏥
- Strong compliance with international safety regulations 🌐
- End-to-end lifecycle safety management
- Higher data quality and regulatory trust
🎯 Who Should Apply
- PV professionals with 2–8 years experience
- Hands-on in post-marketing safety reporting
- Familiar with global ICSR workflows
- Seeking roles in Mumbai, Pune, Nagpur, or Bangalore
- Focused on growth in global regulatory & drug safety careers
📩 How to Apply
Email your updated CV to:
📧 ruchika.kohil@gsshrsolutions.com
Tip: Highlight your PV experience, tools/systems used, and exposure to global health authority reporting.
✨ Final Take
With rising regulatory scrutiny, PV Submission Specialists are in strong demand. This role offers meaningful global exposure, structured processes, and long-term growth in drug safety. If that’s your lane—apply now and move closer to your next milestone. 🚀
