Job Title: Safety Science Coordinator I
Location: Pune, India
Category: Clinical
Job ID: 253818
Fortrea is a leading global Contract Research Organization (CRO) with extensive experience in clinical development across more than 20 therapeutic areas. Operating in ~100 countries, Fortrea provides pharmaceutical, biotechnology, and medical device clients with comprehensive clinical development and technology solutions. The organization fosters a collaborative and innovative work culture defined by its FOUR values: Forward Together, Own It, Uphold Integrity, and Respect People.
The Safety Science Coordinator I supports Clinical Safety and Pharmacovigilance operations for products, including the management of adverse events (AEs) from clinical trials and post-marketing sources. The role involves processing expedited AE reports, maintaining safety databases, assisting with regulatory submissions, and ensuring compliance with quality and regulatory standards.
Adverse Event Management
Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Log incoming AE/SAE reports into departmental tracking systems and forward to centralized mailboxes.
Data entry and management of safety data in tracking systems.
Write patient narratives and code AEs using MedDRA (for marketed products, if applicable).
Conduct listedness assessments against product labels.
Generate queries for missing or discrepant information in consultation with medical staff.
Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, vendors, and internal stakeholders.
Documentation & Reporting
Maintain adverse event tracking systems and project files.
Assist in reconciliation of databases and maintenance of files for AE reporting requirements across countries.
Prepare and coordinate safety study files for archiving at project completion.
Support creation and maintenance of internal and external reports in compliance with SOPs and departmental work instructions.
Quality & Compliance
Ensure operations comply with governing regulatory requirements and study/project-specific plans.
Support peer and quality review of processed reports and trends analysis.
Maintain high standards of data quality, safety, and regulatory compliance.
Training & Collaboration
Train and mentor PSS Assistants or peers in day-to-day activities.
Build and maintain positive relationships across functional units and with clients.
Arrange and schedule internal and external meetings/teleconferences.
Other Duties
Perform additional tasks as assigned by management.
Comply with legal and safety requirements, including Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.
Minimum Requirements
PharmD, MPharm, or BPharm with at least 1 year of relevant experience.
Degree preferred in Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
Relevant experience includes AE/SAE processing, narrative writing, query generation, safety databases, and regulatory submissions.
Experience in pharmaceutical, biotechnology, or CRO industry in Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance.
Proficiency in English and local language for speaking, reading, and writing.
Skills & Competencies
Good team player with peer support capability.
Ability to prioritize and manage multiple tasks.
Attention to detail and accuracy.
Strong written and verbal communication skills.
Logical thinking and ability to proof-read numerical data.
Proficiency with MS Office and standard office equipment.
Office-based or remote work.
Ability to comply with legal and safety requirements.
Pharmacovigilance
Safety Science
Clinical Safety
AE/SAE Reporting
Regulatory Submissions
Clinical Data Management
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