Senior Safety Submission Specialist Pharmacovigilance

Why This Role Matters

In clinical research and post-marketing surveillance, timely and accurate safety reporting is non-negotiable. Regulatory authorities worldwide require expedited reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to ensure patient safety and public health protection.
The Safety Submission Specialist plays a critical operational role in maintaining regulatory compliance by reviewing, preparing, and transmitting Individual Case Safety Reports (ICSRs) to global regulatory agencies and partners. This position directly impacts regulatory credibility, sponsor trust, and patient protection.
Errors or delays in safety reporting can result in regulatory findings, compliance risks, and potential harm to patients. This role ensures that safety submissions are accurate, complete, and aligned with global reporting standards established by authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.

Job Description

The Safety Submission Specialist is responsible for reviewing, preparing, tracking, and transmitting expedited safety reports (paper and electronic) to global regulatory authorities, business partners, affiliates, and other required destinations.
Working with minimal supervision, this role ensures compliance with local and international pharmacovigilance regulations. The specialist maintains up-to-date knowledge of global reporting requirements and supports safety compliance metrics, reconciliation activities, and regulatory intelligence monitoring.
This role requires technical proficiency in safety databases, regulatory submission platforms, and compliance tracking systems, as well as strong organizational and analytical skills.

Key Features of the Role

• Direct involvement in global ICSR submission processes
• Regulatory interaction across multiple international regions
• Exposure to clinical trial and post-marketing pharmacovigilance
• Compliance and deviation management responsibilities
• Cross-functional collaboration with safety, regulatory, and clinical teams

Responsibilities

• Review and transmit expedited ICSRs (paper and electronic) to regulatory authorities and partners.
• Monitor Drug Safety Inbox for submission acknowledgements and confirmation receipts.
• Generate final clinical trial regulatory reports such as CIOMS I, MedWatch 3500A, and XML outputs from the global safety database.
• Prepare and distribute Investigator Safety Letters and final submission documentation.
• Maintain submission trackers and distribution spreadsheets for compliance monitoring.
• Perform case closure and electronic filing of SAE documentation.
• Initiate, investigate, and document expedited reporting deviations, including CAPAs and extension requests.
• Conduct SAE reconciliation activities and raise queries when discrepancies are identified.
• Reconcile and send SUSAR Gap Packs as required.
• Maintain and update expedited reporting email distribution lists.
• Track and reconcile compliance metrics for safety reporting timelines.
• Support generation of overall submission compliance reports for internal review.
• Monitor regulatory intelligence databases for updates in country-specific reporting requirements.
• Contribute regulatory intelligence insights for development of Safety Reporting Plans.
• Ensure documentation is filed in the Trial Master File (TMF) according to SOPs and sponsor requirements.
• Support documentation updates for the Pharmacovigilance System Master File (PSMF) where applicable.
• Maintain compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP requirements, and global drug/device regulations.
• Participate in departmental meetings and ongoing training activities.

Required Qualifications

• Minimum 2 years of experience in clinical trial drug safety within Pharma or CRO environments.
• Demonstrated knowledge of global pharmacovigilance regulations, including FDA, EU, and ICH requirements.
• Working experience with ARGUS Safety Database.
• Experience with reporting portals such as EMA EudraVigilance and UK MHRA systems.
• Bachelor’s degree (BA/BS preferred) in Life Sciences, Pharmacy, or related field.

Educational Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
• Additional pharmacovigilance certifications are advantageous.

Experience and Skills

• Strong understanding of global safety reporting regulations.
• Hands-on experience in ICSR preparation and expedited submissions.
• Familiarity with EudraVigilance and UK MHRA reporting frameworks.
• Experience generating regulatory reports (CIOMS I, MedWatch 3500A, XML).
• Proficiency in safety databases such as ARGUS.
• Strong attention to detail and compliance-driven mindset.
• Analytical thinking with the ability to manage deviations and CAPAs.
• Excellent documentation and tracking capabilities.
• Ability to manage multiple deadlines in a fast-paced regulatory environment.
• Strong communication skills for cross-functional coordination.

Salary Insights

Compensation for a Safety Submission Specialist is competitive and aligned with pharmacovigilance industry standards. Salary packages typically depend on:

• Years of pharmacovigilance experience
• Exposure to global reporting portals
• Technical expertise in safety databases
• Experience handling regulatory deviations and compliance metrics
Additional benefits may include health insurance, retirement plans, paid leave, and employee wellness programs depending on company policy and region.

Company Overview

The organization operates within the pharmaceutical and clinical research domain, supporting global drug development and post-marketing safety programs. With a strong focus on regulatory compliance and patient safety, the company maintains rigorous quality systems and pharmacovigilance frameworks.
Through adherence to international standards and proactive regulatory intelligence monitoring, the organization ensures that all safety reporting obligations are met accurately and within required timelines.

FAQs

1. What is the primary responsibility of a Safety Submission Specialist?
   The primary responsibility is reviewing and submitting expedited ICSRs to global regulatory authorities while ensuring compliance with reporting timelines.

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

3. What regulatory authorities should candidates be familiar with?
   Candidates should understand reporting requirements aligned with the U.S. FDA, European regulations, and ICH guidelines.

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

5. Is experience with EudraVigilance required?
   Yes, familiarity with EMA EudraVigilance and UK MHRA reporting portals is essential.

Application Tips

• Highlight hands-on experience with ICSR submissions and safety databases.
• Demonstrate knowledge of global pharmacovigilance regulations.
• Provide examples of compliance tracking and deviation management.
• Emphasize experience with regulatory portals such as EudraVigilance.
• Showcase your ability to manage strict regulatory timelines without errors.