Job Title: Safety Reporting Specialist – Clinical Research
Location: Bangalore, Karnataka, India
Work Mode: Fully Remote
Employment Type: Full-Time
Job ID: R-01335773
Experience Required: 2+ Years
Industry: Clinical Research / Pharmacovigilance / Drug Safety
Job Overview
We are seeking a Safety Reporting Specialist to join a global clinical research organization supporting end-to-end drug development programs. This role plays a critical part in ensuring accurate, compliant, and timely safety reporting in accordance with global regulatory requirements. The position offers the opportunity to work remotely while collaborating with cross-functional clinical and safety teams on global studies.
Key Responsibilities
Receive, prepare, review, and submit clinical safety reports to regulatory authorities and other applicable stakeholders within defined timelines.
Ensure full compliance with global pharmacovigilance regulations, country-specific legislation, and internal procedural requirements.
Lead and manage large-scale safety reporting projects, ensuring process adherence and on-time submissions.
Monitor regulatory timelines and proactively identify risks related to reporting compliance.
Provide expert input into the development, review, and enhancement of safety reporting SOPs and procedural documents.
Actively contribute ideas for process improvement and operational efficiency, supporting implementation initiatives.
Collaborate with internal departments and participate in cross-functional meetings related to safety reporting activities.
Mentor and guide junior team members, providing technical support and knowledge transfer.
Generate and analyze metrics and operational reports, with exposure to financial and project-related tracking.
Serve as a primary departmental contact on assigned projects, coordinating with internal and external stakeholders.
Skills & Competencies
Strong knowledge of medical terminology and global safety reporting requirements.
Advanced proficiency in Microsoft Office applications and working knowledge of safety databases.
Thorough understanding of pharmacovigilance regulations, timelines, and procedural documentation.
Excellent time management skills with the ability to prioritize and multitask in a fast-paced environment.
High attention to detail and strong quality-focused mindset.
Effective communication, collaboration, and stakeholder management skills.
Ability to influence at multiple organizational levels and work independently with minimal supervision.
Strong analytical, critical thinking, and problem-solving abilities.
Demonstrated ability to coach and support junior colleagues in safety reporting activities.
Education & Experience
Bachelor’s degree or equivalent qualification in Life Sciences, Pharmacy, Nursing, or a related discipline.
Minimum 2 years of relevant experience in safety reporting, pharmacovigilance, or clinical research operations.
Equivalent combinations of education, training, and experience will be considered.
Why Join This Role
Opportunity to work fully remotely within a global clinical research environment.
Exposure to international safety reporting standards and regulatory frameworks.
Collaborative culture with structured learning and mentoring opportunities.
Career growth within pharmacovigilance and clinical safety operations.
About the Organization
Our Clinical Research Services team is part of a leading global Contract Research Organization (CRO) delivering high-impact solutions across the clinical development lifecycle. With deep scientific and operational expertise, the organization supports the advancement of innovative therapies addressing complex global health challenges.
Apply Now
Qualified professionals with experience in drug safety, safety reporting, or clinical research operations are encouraged to apply through thepharmadaily.com.
SEO & GEO Keywords:
Safety Reporting Specialist Jobs India, Pharmacovigilance Jobs Bangalore, Remote Clinical Research Jobs, Drug Safety Careers India, CRO Safety Reporting Roles, Global PV Jobs Remote
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