Job Title: Safety Reporting Specialist – Clinical Research
Location: Bangalore, Karnataka, India
Job Type: Full-Time | Fully Remote
Experience Required: 2+ years in pharmacovigilance, clinical safety reporting, or related field
Company Overview:
Join a leading global contract research organization (CRO) that powers advanced clinical research and accelerates the development of life-saving therapies. Our Clinical Research Services team brings scientific and clinical expertise to deliver innovative solutions, supporting global drug development and regulatory compliance.
Role Overview:
The Safety Reporting Specialist is responsible for receiving, preparing, and submitting safety reports in compliance with regulatory timelines and country-specific legislation. This role ensures the highest standards of pharmacovigilance are maintained while providing mentorship and support to junior team members.
Key Responsibilities:
Receive, review, and prepare safety reports for submission to regulatory authorities and internal stakeholders.
Ensure all safety reports are submitted within established timelines and in compliance with local and global regulations.
Lead large-scale safety reporting projects, coordinating with cross-functional teams to ensure regulatory compliance.
Provide input for the development and improvement of program and departmental procedural documents.
Mentor new team members and provide guidance to colleagues on safety reporting processes.
Collaborate with internal departments and attend meetings to coordinate safety reporting activities.
Generate metrics and reports related to safety submissions; support project-level financial tracking when required.
Business Relationships:
Act as a primary contact for safety reporting on assigned projects.
Interact with internal and external stakeholders, including regulatory authorities, ensuring effective communication and alignment.
Network with senior personnel in clinical research, safety, and pharmacovigilance functions.
Required Knowledge & Skills:
Strong understanding of medical terminology and clinical concepts.
Excellent proficiency in Microsoft Office and familiarity with database systems.
Thorough knowledge of global safety reporting requirements and procedural documentation.
Strong attention to detail, critical thinking, and problem-solving abilities.
Ability to manage multiple priorities and meet deadlines in a collaborative team environment.
Strong interpersonal skills with the ability to influence stakeholders at all levels.
Demonstrated initiative and ability to mentor junior colleagues.
Educational Qualifications:
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or a related field.
Formal academic or vocational qualifications in pharmacovigilance, clinical research, or safety reporting are preferred.
Experience Required:
Minimum 2 years of experience in pharmacovigilance, clinical safety reporting, or a similar role, demonstrating knowledge of regulatory requirements and safety processes.
Why Join Us:
Work with a globally recognized CRO supporting cutting-edge clinical research.
Opportunity for professional growth in pharmacovigilance and safety reporting.
Fully remote role with exposure to cross-functional and international teams.
Competitive remuneration, benefits, and career development opportunities.
Equal Opportunity Employer:
We are committed to providing equal employment opportunities to all candidates. Reasonable accommodations are available for qualified individuals with disabilities.
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