Precision Medicine Group is hiring a Safety Submissions Specialist in Bengaluru, Karnataka for professionals experienced in pharmacovigilance, ICSR submissions, and clinical trial safety reporting. This is an on-site opportunity for candidates with at least 2 years of experience in the Pharma/CRO industry and strong knowledge of global safety reporting regulations.
If you have hands-on experience with ARGUS Safety Database, EudraVigilance, MHRA, FDA reporting, and ICH guidelines, this Safety Submissions Specialist role could be a strategic career move in clinical drug safety operations.
About Precision Medicine Group
Precision Medicine Group is a leading clinical research and life sciences services organization supporting pharmaceutical, biotech, and medical device companies globally. The organization specializes in clinical development, pharmacovigilance, and regulatory compliance.
Job Overview
- Job Title: Safety Submissions Specialist
- Location: Bengaluru
- Industry: Pharmacovigilance / Drug Safety / Clinical Research
- Employment Type: Full-time (On-site)
- Experience Required: Minimum 2 years in clinical trial drug safety
This Safety Submissions Specialist role focuses on reviewing and transmitting Individual Case Safety Reports (ICSRs) to global regulatory authorities, affiliates, and business partners in compliance with international pharmacovigilance regulations.
Key Responsibilities
The Safety Submissions Specialist will:
- Monitor Drug Safety Inbox for submission acknowledgements and expedited report confirmations
- Generate final clinical trial regulatory reports (CIOMS I, MedWatch 3500A, XML formats)
- Review and transmit ICSR submissions (paper & electronic)
- Prepare and distribute Investigator Safety Letters
- Perform SAE case closure and electronic filing
- Conduct SAE reconciliation and send SUSAR Gap Packs
- Complete expedited reporting deviations including CAPA documentation
- Maintain submission/distribution trackers and compliance metrics
- Support development of Safety Reporting Plans
- Monitor regulatory intelligence databases for global updates
- Ensure documentation compliance in TMF and Pharmacovigilance System Master File
- Maintain adherence to GCP, ICH, FDA, EU, and GVP guidelines
This role requires strong operational knowledge of global safety reporting regulations and pharmacovigilance compliance standards.
Required Qualifications
Mandatory:
- Minimum 2 years of experience in clinical trial drug safety / pharmacovigilance
- Working knowledge of:
- FDA safety reporting requirements
- ICH guidelines
- EU Pharmacovigilance regulations
- Hands-on experience with ARGUS Safety Database
- Experience with:
- EMA EudraVigilance
- UK MHRA reporting portals
- Other recognized global submission portals
Preferred:
- BA/BS degree in Life Sciences, Pharmacy, or related field
Salary & Benefits
- Estimated Salary Range: ₹6,00,000 – ₹10,00,000 per annum (based on experience & industry standards in Bengaluru)
- Exposure to global pharmacovigilance operations
- Opportunity to work with multinational regulatory frameworks
- Structured SOP-driven environment
- Equal Opportunity Employer
Why This Safety Submissions Specialist Role Matters
With increasing regulatory scrutiny across FDA, EMA, and MHRA jurisdictions, demand for experienced Safety Submissions Specialists in Bengaluru is rising. Professionals with expertise in ICSR processing, ARGUS database management, expedited reporting, and SUSAR reconciliation are critical to maintaining compliance in global clinical trials.
This opportunity is ideal for candidates looking to advance their career in:
- Drug Safety Operations
- Clinical Trial Pharmacovigilance
- Regulatory Compliance
- Global Safety Reporting
How to Apply
