Safety Reporting Specialist – Clinical Research
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Work Model: Fully Remote
Category: Clinical Research
Job ID: R-01335773
About the Role
Join a leading global Contract Research Organization (CRO) at the forefront of clinical research and drug development. As a Safety Reporting Specialist, you will play a key role in ensuring timely, accurate, and compliant safety reporting across clinical studies, supporting the delivery of life-changing therapies worldwide.
You will interact with cross-functional teams, mentor junior staff, and contribute to the development and refinement of departmental procedures, ensuring that all safety reporting activities adhere to regulatory timelines and country-specific legislation.
Key Responsibilities
Receive, prepare, and submit safety reports to relevant stakeholders, ensuring compliance with all applicable regulatory requirements.
Lead large-scale projects, managing timelines, documentation, and adherence to safety reporting SOPs.
Provide input and feedback on program and departmental procedures to enhance operational efficiency.
Collaborate with internal departments and attend project-related meetings to ensure smooth execution of safety reporting tasks.
Mentor junior team members and provide guidance on safety reporting processes.
Generate metrics and reports to monitor performance and support financial or operational tracking initiatives.
Serve as the primary departmental contact for safety reporting projects, coordinating with senior internal and external personnel.
Required Knowledge, Skills, and Abilities
Strong knowledge of medical terminology and global safety reporting standards.
Proficient in Microsoft Office applications and database management systems.
Excellent understanding of procedural documentation and regulatory compliance requirements.
Strong time management, multitasking, and organizational skills.
Exceptional attention to detail and ability to influence stakeholders at all levels.
Demonstrated critical thinking, problem-solving, and negotiation skills.
Ability to work independently and collaboratively in a team-oriented environment.
Capacity to mentor and assist lower-level colleagues in safety reporting activities.
Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field (or equivalent vocational qualification).
2+ years of experience in clinical safety reporting, pharmacovigilance, or related clinical research roles.
Experience in global clinical trials, regulatory compliance, and cross-functional collaboration is preferred.
Why Join Us
Be part of a globally recognized CRO, contributing to the development of therapies that impact millions of lives.
Work in a fully remote, flexible environment with global exposure to clinical trials across multiple therapeutic areas.
Opportunity to grow your career through mentoring, project leadership, and cross-functional collaboration.
Enhance your expertise in safety reporting, regulatory compliance, and clinical research operations.
Apply now on thepharmadaily.com to join as a Safety Reporting Specialist and be part of a global team shaping the future of clinical research.
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