Safety Reporting Specialist

Jobgether; India; Remote; INR 550,000 - 850,000; Full time

Benefits offered by this job

Fully Remote Work: Opportunity to work

Structured Working Schedule

Career Development

Learning Opportunities

Collaborative Environment

Meaningful Contribution

Professional Growth

Inclusive Workplace

Employee Accommodation Support

Job summary

Jobgether partner company seeks a Safety Reporting Specialist based in India to support pharmacovigilance and clinical research through preparation, submission, and tracking of safety reports across multiple countries.

You will work with project leads and cross-functional teams to ensure regulatory timelines, maintain submission records, and uphold data quality and compliance in global safety reporting processes.

Qualifications

• Education: A bachelor's degree or equivalent qualification, supported by relevant academic or vocational training.
• Experience: 0–2 years in safety reporting, pharmacovigilance, clinical research, regulatory affairs, or related field.

Responsibilities

• Prepare, submit, and track expedited and periodic safety reports to regulatory authorities, clients, and other parties.
• Monitor submissions, maintain records, and escalate delays or issues.
• Support compliance with global safety reporting requirements and SOPs.
• Manage regulatory submission files and ensure audit-ready documentation.
• Coordinate safety reporting activities with project leads and cross-functional teams.
• Generate reports and maintain accuracy in reporting systems and contact details.
• Assist in collecting and validating project metrics for performance reporting.
• Provide administrative support to the safety reporting team.

Skills

Medical Terminology

Regulatory Knowledge

Safety Reporting

Microsoft Office

Communication Skills

Organisational Skills

Attention to Detail

Confidentiality

Teamwork

Problem-Solving

Adaptability

Remote Work Readiness

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Safety database functionality

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety Reporting Specialist based in India.

As a Safety Reporting Specialist, you will support critical pharmacovigilance and clinical research activities by coordinating the preparation, submission, and tracking of safety reports. You will help ensure that regulatory reporting obligations are met accurately and within established timelines across multiple countries. Working alongside project leads and cross-functional teams, you will contribute to the quality and reliability of safety reporting processes. Your responsibilities will include maintaining submission records, managing regulatory documentation, monitoring deadlines, and supporting project performance reporting. This role offers an opportunity to develop expertise in global safety regulations, clinical research operations, and pharmacovigilance systems. If you are detail-oriented, organised, and motivated by work that contributes to safer healthcare outcomes, this position provides a meaningful opportunity to grow your career in the life sciences industry.

Accountabilities

• Safety Report Preparation and Submission: Receive, prepare, and submit expedited and periodic safety reports to the appropriate regulatory authorities, clients, and other relevant parties, ensuring compliance with applicable regulations, country-specific legislation, and reporting timelines.
• Submission Tracking and Documentation: Monitor all safety report submissions, maintain accurate submission records, and retain proof of submission. Promptly elevate potential delays, quality concerns, and reporting issues to the assigned lead or line manager.
• Regulatory Compliance: Support compliance with global safety reporting requirements, regulatory guidelines, internal work practices, and client-specific standard operating procedures (SOPs).
• Regulatory File Management: Prepare, organise, maintain, and archive regulatory submission files in accordance with established procedures, ensuring documentation is complete, accurate, accessible, and audit-ready.
• Project Coordination: Provide operational support to assigned project leads, coordinate safety reporting activities, and contribute to the effective delivery of project milestones. Opportunities may include managing smaller projects independently.
• Cross-Functional Collaboration: Liaise with relevant internal teams and stakeholders to coordinate reporting tasks, resolve operational questions, and ensure the timely exchange of information required for safety reporting activities.
• Reporting Systems and Data Maintenance: Generate reports as required and maintain reporting systems and repositories with accurate, up-to-date contact details and relevant project information.
• Metrics and Performance Reporting: Assist managers in collecting, consolidating, and validating project metrics to support performance monitoring, operational reporting, and continuous improvement.
• Administrative Support: Provide additional administrative and coordination support to the safety reporting team as needed, helping maintain efficient workflows and reliable documentation practices.
• Quality and Accuracy: Apply strong attention to detail when processing safety information, reviewing submission records, and maintaining sensitive data, ensuring that work meets established quality standards.

Requirements

• Education: A bachelor's degree or equivalent qualification, supported by relevant academic or vocational training.
• Professional Experience: Approximately 0–2 years of relevant experience in safety reporting, pharmacovigilance, clinical research, regulatory affairs, or a related field. Equivalent combinations of education, training, and directly relevant experience may also be considered.
• Medical Terminology: Basic understanding of medical terminology and the ability to work accurately with clinical and safety-related information.
• Regulatory Knowledge: Basic familiarity with procedural documentation and global safety reporting requirements, including relevant US Food and Drug Administration (FDA) regulations and guidelines.
• Safety Reporting Knowledge: An understanding of safety report preparation, submission tracking, regulatory documentation, and reporting timelines is beneficial.
• Systems and Software Skills: Proficiency in Microsoft Office applications, particularly tools used for documentation, spreadsheets, and reporting. A basic understanding of safety database functionality is also expected.
• Communication Skills: Good written and verbal communication skills, with the ability to exchange information clearly, document activities accurately, and interact professionally with colleagues across different organisational levels.
• Organisational Skills: Strong time management, prioritisation, and coordination abilities, with the capacity to manage multiple reporting activities and meet strict deadlines.
• Attention to Detail: A careful and methodical approach to reviewing safety reports, validating records, maintaining documentation, and ensuring data accuracy.
• Confidentiality and Professionalism: The maturity and discretion required to handle sensitive clinical, medical, and regulatory information responsibly.
• Teamwork: Ability to collaborate effectively with project leads, colleagues, and cross-functional stakeholders while contributing to shared objectives.
• Problem-Solving Skills: Ability to identify discrepancies, recognise potential reporting issues, follow established procedures, and escalation concerns appropriately.
• Adaptability and Learning: Willingness to develop knowledge of pharmacovigilance processes, regulatory requirements, reporting systems, and clinical research standards in a structured professional environment.
• Remote Work Readiness: Ability to work effectively in a fully remote position while maintaining productivity, accuracy, communication, and adherence to reporting deadlines.

Benefits

• Fully Remote Work: Opportunity to work remotely from India.
• Structured Working Schedule: Standard Monday-to-Friday working arrangement.
• Career Development: Opportunity to build a career in safety reporting, pharmacovigilance, regulatory compliance, and clinical research.
• Learning Opportunities: Gain practical exposure to global safety reporting requirements, regulatory submissions, and clinical research processes.
• Collaborative Environment: Work with experienced project leads and cross-functional teams in an international life sciences setting.
• Meaningful Contribution: Support activities that help maintain patient safety and the quality of clinical research and healthcare-related services.
• Professional Growth: Develop project coordination, regulatory documentation, reporting, and quality management skills.
• Inclusive Workplace: Access to a professional environment that values collaboration, innovation, accessibility, and equal employment opportunities.
• Employee Accommodation Support: Reasonable accommodations are available for qualified individuals with disabilities during the recruitment process and when performing essential job functions.