Safety Reporting Specialist – Clinical Research
Job ID: R-01335773
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Location: Bangalore, Karnataka, India (Remote)
Work Schedule: Standard (Monday to Friday)
Work Environment: Office / Remote
About the Organization
Our Clinical Research Services team plays a critical role in accelerating the development of life-saving therapies. As part of a leading global Contract Research Organization (CRO) powering the PPD® clinical research portfolio, the team delivers high-quality scientific, regulatory, and clinical expertise to support drug development programs addressing complex global health challenges.
Role Overview
The Safety Reporting Specialist is responsible for the accurate, timely, and compliant preparation and submission of safety reports to regulatory authorities, sponsors, and other applicable stakeholders. This role supports global pharmacovigilance operations and ensures adherence to international regulatory requirements, country-specific legislation, and internal standard operating procedures. The position requires strong collaboration, regulatory knowledge, and attention to detail within a fast-paced clinical research environment.
Experience Required
Minimum 2+ years of relevant experience in safety reporting, pharmacovigilance, or clinical research operations
Experience within a CRO or global clinical trial environment is preferred
Educational Qualifications
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related field
Relevant formal academic or vocational qualifications in pharmacovigilance or clinical research are advantageous
Key Responsibilities
Receive, prepare, review, and submit safety reports in compliance with global regulatory timelines and country-specific legislation
Monitor ongoing safety reporting activities to ensure continuous regulatory compliance
Lead and support large-scale safety reporting projects, ensuring adherence to agreed processes and submission deadlines
Contribute to the development, review, and continuous improvement of program-level and departmental procedural documents
Collaborate cross-functionally with internal teams and external stakeholders to manage safety reporting deliverables
Serve as a primary departmental contact for assigned projects and client interactions
Mentor new team members and provide guidance, feedback, and technical support
Prepare safety metrics and support reporting activities, including limited involvement in financial and project tracking
Business and Stakeholder Interaction
Represent the safety reporting function on assigned projects
Interact with internal and external stakeholders on complex safety-related matters
Coordinate across functional areas to ensure alignment on pharmacovigilance deliverables
Build professional relationships with senior internal and external stakeholders within the clinical research ecosystem
Required Knowledge and Skills
Strong knowledge of medical terminology and global safety reporting regulations
Thorough understanding of pharmacovigilance procedural documentation and regulatory compliance standards
Proficiency in Microsoft Office applications and familiarity with safety databases
Excellent time management, multitasking, and organizational skills
High attention to detail and strong data quality focus
Ability to influence, communicate, and collaborate effectively across organizational levels
Demonstrated critical thinking, problem-solving, and decision-making skills
Ability to mentor junior team members and support knowledge sharing within the safety reporting function
Why Join Us
Opportunity to work with a globally recognized clinical research organization
Exposure to international pharmacovigilance and regulatory operations
Fully remote work environment with structured work schedules
Collaborative, knowledge-driven culture supporting professional development
Meaningful contribution to the development of therapies that improve global health outcomes
Equal Opportunity Statement
The organization is committed to providing equal employment opportunities to all qualified applicants. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, gender, age, disability, or any other protected status.
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