Job Title: Senior Safety Reporting Specialist
Job Type: Full-Time | Permanent
Location: Remote, India (Fully Remote)
Category: Clinical Research / Pharmacovigilance / Safety Reporting
Job ID: R-01336116
Experience Required: Minimum 3+ years
Work Schedule: Monday to Friday (Standard Business Hours)
Our Clinical Research Services team operates at the forefront of global drug development, delivering scientific and clinical excellence to accelerate therapies that address complex and critical health challenges. As part of a leading global Contract Research Organization (CRO), the team supports a robust clinical research portfolio, enabling life-saving treatments to reach patients worldwide.
We are seeking an experienced Senior Safety Reporting Specialist to manage end-to-end safety reporting activities across clinical research projects. This role is fully remote and ideal for professionals with strong expertise in global pharmacovigilance regulations, expedited and periodic safety reporting, and cross-functional collaboration. The position involves project leadership, regulatory compliance oversight, mentoring junior team members, and contributing to continuous process improvements.
Manage the receipt, preparation, submission, and tracking of expedited and periodic safety reports in compliance with global regulatory timelines and country-specific legislation
Ensure accuracy, quality, and timeliness of safety reports, proactively identifying and resolving issues
Lead large-scale safety reporting projects and programs, ensuring adherence to defined processes and regulatory requirements
Serve as a primary safety reporting contact for assigned projects, liaising with internal and external stakeholders
Provide input into the development and maintenance of SOPs, work instructions, and regulatory intelligence initiatives
Mentor and support junior team members, including onboarding and ongoing training
Participate in cross-functional meetings related to safety reporting and clinical operations
Prepare metrics, reports, and contribute to selected financial or project tracking activities
Support continuous improvement initiatives within the safety reporting function
Bachelor’s degree or equivalent in life sciences, pharmacy, medicine, or a related discipline
Minimum 3+ years of relevant experience in safety reporting, pharmacovigilance, or clinical research within a CRO, pharmaceutical, or biotechnology environment
Strong understanding of global safety reporting regulations, procedural documents, and compliance requirements
Proficiency in medical terminology and safety databases
Advanced Microsoft Office skills and good understanding of database functionality
Proven ability to manage multiple priorities in a fast-paced, global environment
Excellent written and verbal communication skills
Strong attention to detail and quality-driven mindset
Effective time management and multitasking abilities
Critical thinking and problem-solving skills
Ability to influence and collaborate with stakeholders at all organizational levels
Demonstrated leadership, mentoring, and project management capabilities
Strong negotiation, persuasion, and interpersonal skills
Fully remote opportunity within a globally recognized clinical research organization
Exposure to complex, multinational clinical research projects
Career growth in pharmacovigilance and clinical safety leadership
Collaborative, knowledge-driven work culture focused on innovation and quality
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