Safety Submission Specialist - Clinical Trials

Why This Role Matters

In global drug development, patient safety is the highest priority. Regulatory authorities require strict adherence to expedited safety reporting timelines to ensure that emerging safety signals are identified and addressed promptly. The Safety Submission Specialist plays a mission-critical role in ensuring that Individual Case Safety Reports (ICSRs) are accurately reviewed, documented, and submitted within mandated timelines.
This role directly supports compliance with global pharmacovigilance regulations established by authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Failure to comply with safety reporting obligations can result in regulatory findings, inspection observations, or significant reputational and financial risk.
By ensuring accurate submission of expedited reports, maintaining compliance metrics, and monitoring regulatory updates, the Safety Submission Specialist contributes directly to safeguarding patients and maintaining the integrity of clinical trials and post-marketing programs.

Job Description

The Safety Submission Specialist is responsible for reviewing, preparing, and transmitting required ICSRs in both electronic and paper formats to global regulatory agencies, business partners, affiliates, and other designated recipients. Working with minimal supervision, this role ensures adherence to local and international pharmacovigilance requirements.
The position requires strong operational expertise in safety databases, regulatory portals, compliance tracking systems, and documentation management processes. In addition to submission responsibilities, the specialist supports reconciliation activities, deviation management, regulatory intelligence monitoring, and compliance metric reporting.
This role demands accuracy, attention to detail, regulatory awareness, and the ability to work effectively in a deadline-driven environment.

Key Features of the Role

• Direct involvement in global ICSR submission processes
• Exposure to both clinical trial and post-marketing pharmacovigilance programs
• Responsibility for compliance metrics and deviation management
• Interaction with international regulatory reporting portals
• Cross-functional collaboration with safety, regulatory, and clinical teams

Essential Responsibilities

• Review and transmit expedited ICSRs to global regulatory agencies and partners.
• Monitor the Drug Safety Inbox for submission acknowledgements and confirmations.
• Maintain submission trackers, distribution logs, and compliance spreadsheets.
• Generate regulatory reports such as CIOMS I, MedWatch 3500A, and XML files from the global safety database.
• Prepare and distribute Investigator Safety Letters and final submission documentation.
• Perform case closure and ensure electronic filing of SAE documentation.
• Initiate and manage expedited reporting deviations, including investigations, extension requests, and CAPAs.
• Conduct SAE reconciliation activities and issue queries as required.
• Reconcile and send SUSAR Gap Packs in accordance with reporting timelines.
• Maintain and update expedited reporting distribution lists.
• Track and reconcile compliance metrics to ensure adherence to submission timelines.
• Support generation of distribution and submission compliance reports.
• Monitor regulatory intelligence databases for updates to global reporting requirements.
• Provide country-specific reporting insights to support Safety Reporting Plan development.
• Ensure documentation is filed in the Trial Master File (TMF) according to SOPs and sponsor requirements.
• Support updates to the Pharmacovigilance System Master File (PSMF) for post-marketing programs.
• Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP, and global drug/device regulations.
• Participate in department meetings and continuous training activities.

Required Qualifications

• Minimum 2 years of experience in clinical trial drug safety within a Pharma or CRO environment.
• Demonstrated understanding of global safety reporting regulations and pharmacovigilance guidelines.
• Experience with ARGUS Safety Database.
• Hands-on experience with regulatory reporting portals including EMA EudraVigilance and UK MHRA systems.
• Bachelor’s degree (BA/BS preferred) in Life Sciences, Pharmacy, or related discipline.

Educational Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related scientific field.
• Additional training or certification in pharmacovigilance is advantageous.

Experience and Skills

• Strong working knowledge of global pharmacovigilance regulations, including FDA and EU requirements.
• Practical experience preparing and submitting expedited safety reports.
• Familiarity with EudraVigilance and MHRA reporting frameworks.
• Ability to generate regulatory forms such as CIOMS I and MedWatch 3500A.
• Proficiency in safety databases (ARGUS preferred).
• Excellent documentation and tracking skills.
• Strong analytical and problem-solving capabilities.
• Ability to manage strict timelines and multiple priorities.
• High attention to detail and compliance-focused mindset.
• Effective communication and cross-functional collaboration skills.

Salary Insights

Compensation for this role is competitive within the Indian pharmacovigilance and CRO market. Salary structure may depend on:
• Years of safety reporting experience
• Regulatory portal expertise
• Technical proficiency in ARGUS and compliance systems
• Exposure to global pharmacovigilance programs

In addition to base salary, employees may receive performance incentives, health benefits, paid leave, and other company-sponsored programs aligned with regional standards.

Company Overview

This position is part of the Clinical Solutions Business Unit under Precision for Medicine, a global organization specializing in clinical research, biomarker-driven development, and regulatory support services. The division focuses on delivering high-quality clinical trial management and pharmacovigilance services to pharmaceutical and biotechnology partners.
The organization emphasizes ethical conduct, regulatory excellence, and patient-centric research practices. Employees benefit from a structured environment that supports professional growth, compliance excellence, and international exposure.

FAQs

1. What is the primary focus of this role?
   Reviewing and submitting expedited ICSRs to global regulatory authorities while maintaining compliance with pharmacovigilance regulations.

2. Is experience with ARGUS mandatory?
   Yes, working knowledge of the ARGUS Safety Database is required.

3. Which regulatory systems should candidates be familiar with?
   Experience with EMA EudraVigilance, UK MHRA, and other recognized reporting portals is required.

4. Does this role include deviation management?
   Yes, the specialist handles expedited reporting deviations, investigations, and CAPAs.

5. Is this role specific to clinical trials only?
   The role supports both clinical trial programs and post-marketing pharmacovigilance activities.

Application Tips

• Highlight direct experience with expedited ICSR submissions.
• Emphasize knowledge of global pharmacovigilance regulations and reporting timelines.
• Provide examples of compliance tracking and deviation management.
• Mention hands-on experience with ARGUS and regulatory portals.
• Demonstrate your ability to manage deadlines in a highly regulated environment.