Job Title: Safety Submissions Specialist – Clinical Trial Services
Location: Bangalore, Karnataka, India
Job Type: Regular, Full-Time
Division: Clinical Solutions
Business Unit: Precision for Medicine
Requisition Number: 6488
Company: Precision for Medicine
Job Overview
The Safety Submissions Specialist – Clinical Trial Services is responsible for the review, preparation, and timely transmission of Individual Case Safety Reports (ICSRs) to global regulatory authorities, affiliates, and business partners. This role requires in-depth knowledge of global pharmacovigilance regulations, expedited reporting requirements, and clinical trial safety compliance standards.
The ideal candidate will have strong expertise in global safety reporting frameworks, regulatory intelligence monitoring, and safety database systems, ensuring full compliance with FDA, EMA, ICH, and EU pharmacovigilance requirements.
Key Responsibilities
Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
Maintain submission trackers and distribution logs for regulatory compliance
Generate final clinical trial regulatory reports (CIOMS I, MedWatch 3500A, XML) from the global safety database
Prepare and distribute submission documentation, including Investigator Safety Letters
Perform case closure and electronic filing of SAE documentation
Initiate, investigate, and manage expedited reporting deviations, including CAPAs and extension requests
Conduct SAE reconciliation and manage safety queries
Reconcile and distribute SUSAR Gap Packs
Maintain and update expedited reporting distribution lists
Reconcile and track compliance metrics for safety submissions
Support generation of regulatory distribution and submission performance metrics
Monitor regulatory intelligence databases and provide country-specific reporting requirements
Ensure documentation is filed within the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) in accordance with sponsor and company SOPs
Maintain compliance with SOPs, Work Instructions, ICH guidelines, GCP, GVP, and global drug/biologic/device regulations
Participate in departmental and cross-functional meetings
Educational Qualification
Bachelor’s degree (BA/BS) in Life Sciences, Pharmacy, or related discipline preferred
Experience Required
Minimum 2 years of experience in Clinical Trial Drug Safety within a Pharmaceutical or CRO environment
Demonstrated knowledge of global safety reporting regulations including FDA, ICH, and EU pharmacovigilance requirements
Hands-on experience with ARGUS Safety Database
Experience with regulatory portals including EMA EudraVigilance and UK MHRA reporting systems
Strong understanding of expedited reporting processes and compliance metrics
Core Competencies
Global pharmacovigilance and ICSR submission expertise
Regulatory intelligence monitoring
Strong documentation and audit readiness skills
Attention to detail with compliance-driven mindset
Ability to work independently with minimal supervision
Cross-functional collaboration and stakeholder communication
Why Join Precision for Medicine?
Precision for Medicine is a global clinical research organization delivering integrated drug development solutions. The Clinical Solutions division focuses on high-quality safety reporting, regulatory compliance, and pharmacovigilance excellence across global clinical trials.
This role offers exposure to global regulatory environments, advanced safety systems, and opportunities for professional growth in clinical trial pharmacovigilance operations.
Important Notice
Precision for Medicine does not extend employment offers without formal communication from its recruitment team and completion of an official interview process. Candidates are advised to exercise caution regarding fraudulent job offers.
This job posting is optimized for search visibility in global clinical research, pharmacovigilance, and drug safety careers across India and international markets on ThePharmaDaily.com.
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