Are you an experienced Pharmacovigilance professional looking to advance your career in ICSR submission and regulatory reporting? Synapmed is hiring a Senior Drug Safety Associate โ ICSR Submission in Hyderabad (Hybrid). This role is ideal for candidates with 3โ6 years of PV experience, especially in E2B(R3) submissions, regulatory timelines (7/15-day), and global safety reporting.
This opportunity offers hands-on exposure to global regulatory authorities like USFDA, MHRA, and Health Canada, making it a strong career move for professionals aiming to grow in drug safety and pharmacovigilance operations.
Key Responsibilities โ ICSR Submission & PV Operations
- Perform electronic submission of ICSRs (Serious & Non-Serious) to global regulatory authorities
- Submit safety reports to agencies like USFDA, MHRA (UK), EVC, Health Canada
- Ensure compliance with 7-day and 15-day reporting timelines
- Conduct submission readiness checks (case completeness, reportability, timelines)
- Monitor submission queues and regulatory gateways
- Track acknowledgements and resolve submission errors/rejections
- Maintain compliance with SOPs, PV guidelines, and regulatory standards
- Support audits, inspections, and PV training activities
- Coordinate with business and licensing partners for safety submissions
Required Qualifications & Skills
Education
- Bachelorโs degree in Pharmacy, Life Sciences, Nursing, or related field
Experience
- 3โ6 years in Pharmacovigilance (PV)
- Minimum 2โ3 years in ICSR regulatory submissions
Core Skills
- Strong knowledge of ICSR submission & regulatory reporting
- Hands-on experience with E2B(R3) electronic submissions
- Understanding of global PV regulations
- Expertise in 7/15-day reporting timelines
- Experience with safety databases and regulatory gateways
- High attention to detail and compliance mindset
- Strong communication and coordination skills
Salary & Benefits
- ๐ฐ Estimated Salary: โน6 LPA โ โน10 LPA (based on experience & market standards)
- ๐ข Work Mode: Hybrid (Hyderabad)
- ๐ Exposure to global pharmacovigilance systems & audits
- ๐ Work with international regulatory authorities
- ๐ Career growth in drug safety and regulatory submissions
Why This Role is High-Demand (SEO Insight)
The demand for ICSR submission specialists and drug safety associates is rapidly increasing due to stricter global pharmacovigilance regulations. Skills like E2B(R3), regulatory submissions, and PV compliance are among the most searched keywords in pharma jobs.
How to Apply
