Safety Science Coordinator I | Full-Time | Pune, India
Experience Required: 2+ years
Job Description:
We are seeking a detail-oriented Safety Science Coordinator I to support clinical safety and pharmacovigilance operations in Pune. This role focuses on the management and processing of adverse events (AEs), serious adverse events (SAEs), and periodic safety reports (PSRs) across clinical trials and post-marketing activities. The ideal candidate will ensure high-quality, compliant safety data handling, regulatory reporting, and effective coordination with internal and external stakeholders.
Key Responsibilities:
Process expedited safety reports (ESRs) and periodic safety reports (PSRs), ensuring timely submission to clients, regulatory authorities, ethics committees, and study investigators.
Maintain adverse event tracking systems and project documentation, including central files and study-specific files.
Enter safety data accurately into tracking systems, write patient narratives, and code adverse events using MedDRA.
Conduct listedness assessments for marketed products, generate queries for missing or discrepant information, and collaborate with medical staff as needed.
Support database reconciliation, quality review of processed reports, and analysis of trends and corrective actions.
Ensure compliance with study/project-specific plans, SOPs, and the Quality Management System framework.
Train and mentor PSS assistants or peers on day-to-day pharmacovigilance processes.
Schedule and coordinate internal and external meetings or teleconferences.
Build and maintain effective working relationships across functional units.
Provide administrative support and assist in archiving safety study files at project completion.
Qualifications & Experience:
Bachelor’s or Master’s degree in Pharmacy (BPharm/MPharm), Nursing, Medical Sciences, Life Sciences, or related field.
Minimum 2 years of experience in clinical trial case processing, safety reporting, or pharmacovigilance.
Hands-on experience with AE/SAE report processing, narrative writing, regulatory submissions, and safety databases.
Experience in pharmaceutical, biotechnology, or CRO settings, including Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance.
Strong English communication skills (speaking, reading, and writing).
Excellent attention to detail, ability to manage multiple tasks, and strong organizational skills.
Proficiency in MS Office, Windows, and standard office equipment.
Location: Pune, India
Why Join Us:
Engage in global clinical safety projects with a focus on regulatory compliance and quality.
Collaborate with multidisciplinary teams in a dynamic pharmaceutical research environment.
Opportunity for professional growth, training, and development in pharmacovigilance and clinical operations.
Work in a supportive, inclusive workplace committed to high standards and employee well-being.
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