Safety Science Coordinator I | Full-Time | Pune, India
Experience Required: 2+ years
Job Description:
We are looking for a detail-oriented Safety Science Coordinator I to support clinical safety and pharmacovigilance operations in Pune. This role is responsible for managing adverse event reporting processes across clinical trials and post-marketing activities, ensuring high-quality safety data handling and compliance with global regulatory standards.
The ideal candidate will have hands-on experience in case processing, safety reporting, and working with safety databases within a pharmaceutical, biotechnology, or CRO environment.
Key Responsibilities:
Safety Case Processing & Reporting
Process and manage Adverse Events (AEs) and Serious Adverse Events (SAEs) from clinical trials and post-marketing sources.
Prepare and submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to clients, regulatory authorities, ethics committees, and investigators within defined timelines.
Perform accurate data entry into safety databases and maintain adverse event tracking systems.
Write patient safety narratives and code adverse events using MedDRA.
Conduct listedness assessments for marketed products, where applicable.
Generate and resolve data queries in collaboration with medical and clinical teams.
Data Quality & Compliance
Ensure all incoming AE/SAE reports are logged, tracked, and processed in compliance with SOPs and regulatory requirements.
Support peer and quality review of safety reports, identifying trends and implementing corrective actions.
Assist in database reconciliation and ensure consistency across safety systems.
Maintain documentation related to global adverse event reporting requirements.
Ensure adherence to Quality Management Systems, including SOPs and work instructions.
Coordination & Support
Prepare and maintain project files and central documentation for safety studies.
Support audit and inspection readiness, including documentation and compliance checks.
Coordinate and schedule internal and external meetings or teleconferences.
Assist in archiving safety study files upon project completion.
Provide administrative and operational support to pharmacovigilance teams.
Collaboration & Training
Build strong working relationships with cross-functional teams and stakeholders.
Train and mentor junior team members or peers in safety processes and systems.
Contribute to continuous improvement initiatives to enhance quality and efficiency.
Qualifications & Experience:
Bachelor’s or Master’s degree in Pharmacy (BPharm/MPharm), PharmD, Nursing, Medical Sciences, Life Sciences, or related field.
Minimum 2 years of experience in clinical trial safety case processing or pharmacovigilance.
Hands-on experience with AE/SAE processing, narrative writing, safety databases, and regulatory submissions.
Experience in pharmaceutical, biotechnology, or CRO environments is preferred.
Strong understanding of global pharmacovigilance regulations and reporting requirements.
Excellent written and verbal communication skills in English.
Strong attention to detail, organizational, and multitasking abilities.
Proficiency in MS Office and standard computer applications.
Location: Pune, India
Why Join Us:
Work on global pharmacovigilance and clinical safety projects.
Gain exposure to regulatory reporting and safety data management processes.
Collaborate with experienced professionals in a dynamic clinical research environment.
Access opportunities for professional development and career growth in drug safety.
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