Safety Science Coordinator I
Location: Pune, India
Employment Type: Full-Time
Job Requisition ID: 255857
Application Deadline: December 16, 2025
Job Overview
We are seeking a detail-oriented Safety Science Coordinator I to support Clinical Safety and Patient Safety Services (PSS) operations across clinical trial and post-marketing environments. This role involves end-to-end management of adverse event (AE) and serious adverse event (SAE) processes, including expedited reporting, regulatory submissions, and safety data quality oversight.
The Safety Science Coordinator I will work either as part of a client project team or as a standalone service provider, ensuring compliance with global regulatory requirements, internal quality standards, and agreed timelines. This position plays a critical role in maintaining patient safety, data integrity, and regulatory compliance throughout the product lifecycle.
Key Responsibilities
Clinical Safety & Pharmacovigilance Operations
Assist in the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) within defined timelines.
Manage safety data from clinical trials and post-marketing sources, including unsolicited adverse event reports.
Ensure accurate logging, tracking, and routing of AE/SAE reports through safety databases and centralized mailboxes.
Adverse Event Case Processing
Perform safety data entry into adverse event tracking systems.
Write clear, compliant patient narratives and code adverse events using MedDRA terminology.
Support listedness assessment against approved product labels for marketed products.
Generate and manage queries to resolve missing, inconsistent, or unclear safety information in collaboration with medical reviewers.
Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, partners, and vendors within agreed timelines.
Quality & Compliance
Support peer review and quality checks of safety reports and contribute to trend analysis and corrective actions.
Assist with reconciliation of safety databases, where applicable.
Maintain documentation related to global adverse event reporting requirements.
Work in accordance with the Quality Management System (QMS), including SOPs, work instructions, and project-specific plans.
Ensure compliance with applicable regulatory guidelines and health and safety requirements.
Coordination & Administrative Support
Maintain project files, safety study documentation, and archival readiness at project close-out.
Arrange and coordinate internal and external meetings or teleconferences.
Provide administrative and operational support to Patient Safety Services personnel.
Train and mentor PSS Assistants or peers in routine safety activities.
Build and maintain effective cross-functional working relationships.
Perform additional duties as assigned to support safety operations.
Qualifications
Education & Experience (Minimum Requirements)
Non-degree: 1–2 years of safety or relevant industry experience
Associate Degree: 6 months to 1 year of safety or relevant experience
Bachelor’s Degree (BS/BA): 0–1 year of safety or relevant experience
Master’s Degree (MS/MA): 0–6 months of safety or relevant experience
PharmD: 0–6 months of safety experience (one-year residency or fellowship may be considered equivalent experience)
Preferred fields of study:
Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related disciplines.
Safety Experience Includes
Processing AE/SAE cases
Writing patient narratives
Generating safety queries
Working with safety databases
Regulatory safety submissions
Relevant Industry Experience May Include
Pharmacovigilance
Medical Affairs
Clinical Data Management
Clinical Data Entry or Monitoring
Regulatory Affairs
Quality Assurance
Experience in pharmaceutical, biotechnology, or CRO environments
Equivalent and relevant experience may be considered in place of formal education.
Skills & Competencies
Strong attention to detail and data accuracy
Ability to manage multiple tasks and prioritize effectively
Excellent written and verbal communication skills
Strong logical reasoning and proofreading abilities
Proficiency in MS Office and Windows-based applications
Good keyboarding and administrative skills
Team-oriented mindset with willingness to support peers
Language Requirements
Speaking: English and local language
Reading/Writing: English and local language
Work Environment
Office-based or remote work environment
Standard office equipment usage required
Equal Opportunity Statement:
The organization is committed to providing equal employment opportunities and supporting workplace accommodations in accordance with applicable regulations.
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