Safety Reporting Specialist – Clinical Research
Location: Bangalore, Karnataka, India
Job ID: R-01335773
Job Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-Based
Job Overview
A leading global contract research organization within Thermo Fisher Scientific’s clinical research division is seeking a highly skilled Safety Reporting Specialist to support global pharmacovigilance and safety reporting operations. The role involves managing safety report submissions, ensuring compliance with regulatory requirements, and contributing to clinical research processes that accelerate the development of therapies addressing critical global health challenges.
The position requires strong knowledge of global safety reporting standards, regulatory timelines, and clinical research procedures, along with the ability to manage projects and collaborate with cross-functional teams.
Key Responsibilities
Receive, prepare, and submit safety reports to regulatory authorities and relevant stakeholders in compliance with global regulations and country-specific legislation.
Monitor and ensure adherence to safety reporting timelines and regulatory requirements.
Lead large-scale safety reporting projects and ensure deliverables meet agreed processes and compliance standards.
Provide input to support the development and enhancement of program and departmental procedures.
Collaborate with internal departments and participate in cross-functional meetings related to safety reporting activities.
Mentor new team members and provide guidance to junior colleagues in safety reporting processes.
Generate performance metrics and contribute to project-related financial tracking activities.
Represent the department as a primary contact for safety reporting activities on assigned projects.
Build and maintain relationships with internal and external stakeholders across functional areas.
Required Skills and Competencies
Strong knowledge of medical terminology and pharmacovigilance processes.
Advanced proficiency in Microsoft Office applications and understanding of database functionality.
Comprehensive understanding of global safety reporting regulations and procedural documentation.
Excellent time management and multitasking capabilities.
Strong attention to detail and quality-focused approach.
Ability to influence stakeholders across organizational levels.
Effective collaboration and teamwork skills in a global environment.
Strong analytical thinking, problem-solving, and decision-making abilities.
Demonstrated initiative with effective negotiation and communication skills.
Educational Qualifications and Experience Required
Bachelor’s degree or equivalent academic or vocational qualification in life sciences, pharmacy, or a related discipline.
Minimum 2+ years of relevant experience in clinical research, pharmacovigilance, or safety reporting.
Proven experience managing safety reporting activities in compliance with regulatory guidelines is preferred.
Accessibility and Equal Opportunity
The organization is committed to providing reasonable accommodations for individuals with disabilities throughout the recruitment process and employment lifecycle.
Uttar Pradesh :
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