Safety Submissions Specialist - Clinical Trial Pharmacovigilance

Why This Role Matters
The Safety Submissions Specialist plays a critical role in global clinical trial safety reporting. With increasing regulatory scrutiny from authorities such as the FDA, EMA, and MHRA, timely and accurate submission of safety reports is essential to maintain compliance and protect patient safety. This role directly supports regulatory adherence, audit readiness, and risk mitigation in global clinical trials. It is a strategic opportunity for professionals looking to strengthen their expertise in pharmacovigilance operations and international safety reporting.

Job Description
The Safety Submissions Specialist is responsible for reviewing, preparing, and transmitting Individual Case Safety Reports (ICSRs) and other regulatory safety documents to global health authorities, affiliates, and business partners. The role requires strong knowledge of international safety regulations, electronic submission systems, and pharmacovigilance databases.

Key Features of the Role
• Direct exposure to global clinical trial safety submissions
• Hands-on experience with ICSR electronic transmission and regulatory portals
• Interaction with international regulatory authorities
• Involvement in TMF compliance and Safety Reporting Plans
• Growth opportunity in drug safety and regulatory compliance
• Work within FDA, EU, UK, and ICH safety frameworks

Responsibilities Required
• Monitor Drug Safety Inbox for acknowledgements and expedited reporting confirmations
• Generate final clinical trial regulatory reports (CIOMS I, MedWatch 3500A, XML formats)
• Review and transmit ICSR submissions (paper and electronic formats)
• Prepare and distribute Investigator Safety Letters
• Perform SAE case closure and electronic filing
• Conduct SAE reconciliation and distribute SUSAR Gap Packs
• Manage expedited reporting deviations and support CAPA documentation
• Maintain submission trackers, compliance logs, and reporting metrics
• Support development and updates of Safety Reporting Plans
• Monitor global regulatory intelligence updates
• Ensure documentation compliance within TMF and PSMF
• Maintain adherence to GCP, ICH, FDA, EU GVP, and MHRA guidelines

Qualifications
Candidates must have strong operational knowledge of clinical trial safety reporting and global pharmacovigilance regulations. Experience working in Pharma or CRO environments is preferred.

Educational Requirements
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• B.Pharm / M.Pharm / PharmD preferred
• Pharmacovigilance certification is an added advantage

Experience and Skills
Experience:
• Minimum 2 years in clinical trial drug safety or pharmacovigilance
• Experience in Pharma or CRO setting

Technical Skills:
• Knowledge of FDA safety reporting requirements
• Understanding of ICH guidelines (E2A, E2B, E6)
• Familiarity with EU Pharmacovigilance regulations and GVP modules
• Hands-on experience with ARGUS Safety Database
• Experience with EMA EudraVigilance portal
• Experience with UK MHRA reporting systems
• Familiarity with other global electronic submission portals

Functional Skills:
• Strong attention to detail
• Excellent documentation and compliance practices
• Ability to manage multiple submissions within strict timelines
• Strong coordination and communication skills
• Analytical mindset for reconciliation and deviation handling

Salary Insights
• Estimated salary range in Bengaluru: ₹5.5 LPA – ₹10 LPA (for 2–4 years experience)
• Compensation depends on ARGUS expertise, regulatory exposure, and CRO experience
• Additional benefits may include insurance, performance bonuses, and career development programs

Company Overview
Precision Medicine Group is a global clinical research and life sciences services organization supporting pharmaceutical, biotech, and medical device companies. The company specializes in clinical development, pharmacovigilance, and regulatory compliance services, helping sponsors accelerate drug development while maintaining global compliance standards.

FAQs

1. Is this role focused on clinical trials or post-marketing safety?
   This role primarily supports clinical trial safety reporting.

2. Is ARGUS experience mandatory?
   Hands-on ARGUS experience is strongly preferred.

3. Is this a remote role?
   No, this is an on-site position in Bengaluru.

4. Does the role involve global submissions?
   Yes, submissions may involve FDA, EMA, MHRA, and other authorities.

5. Is CRO experience required?
   CRO experience is preferred but not mandatory.

Application Tips
• Clearly highlight ARGUS database experience in your CV
• Mention exposure to ICSR submissions (E2B, XML, CIOMS, MedWatch)
• Include examples of expedited reporting and SUSAR reconciliation
• Demonstrate familiarity with FDA, EU, and MHRA regulations
• Quantify your experience (e.g., number of submissions handled per month)
• Emphasize audit readiness and compliance accuracy experience