Job Title:
Safety Science Coordinator I
Company:
Fortrea
🌐 www.fortrea.com
Job Details:
Job ID: 253818
Category: Clinical
Location: Pune, India
Work Environment: Office-based or remote (as applicable)
Job Overview:
The Safety Science Coordinator I will support the clinical safety and/or post-marketing safety surveillance (PSS) operations for assigned products. This includes managing adverse event (AE) data, maintaining tracking systems, and supporting regulatory compliance. The role is key to ensuring high-quality safety data is processed, reviewed, and submitted in a timely and compliant manner to clients and regulatory authorities.
Key Responsibilities:
📋 Safety Data Processing
Assist with the processing of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Maintain adverse event tracking systems and ensure data is accurately logged and up-to-date.
Ensure timely submission of reports to:
Clients
Regulatory Authorities
Ethics Committees
Investigators
Fortrea project personnel
💻 Case Management
Log and forward AE/SAE reports to the centralized mailbox.
Enter safety data into tracking systems and write patient narratives.
Code adverse events using MedDRA (especially for marketed products).
Conduct listedness assessments against product labels (as applicable).
Generate queries for missing or discrepant information, with input from medical staff.
Assist in peer/quality review of reports and support with trending analysis.
📂 Documentation & Filing
Set up and maintain project documentation and central files.
Support database reconciliation efforts.
Maintain country-specific AE reporting requirement files.
Prepare study files for archiving at project completion.
🤝 Communication & Support
Schedule and arrange internal/external meetings or teleconferences.
Provide administrative support to PSS personnel.
Build strong internal relationships within the Pharmacovigilance Safety Services (PSS) team.
Train and mentor peers or junior staff in day-to-day responsibilities.
⚖️ Compliance
Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), and company’s Quality Management System (QMS).
Comply with applicable safety regulations including:
Health and Safety at Work Act 1974 (UK)
COSHH Regulations 1989
EC Directives 1992/3
🔄 Other
Perform additional duties as required or assigned by management.
Minimum Qualifications:
🎓 Education:
PharmD, MPharm, or BPharm with at least 1 year of relevant experience
Degree should ideally be in: Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field
🧠 Experience:
Prior experience in:
AE/SAE case processing
Narrative generation
Query creation and resolution
Use of safety databases
Regulatory submission processes
Relevant fields include: Pharmacovigilance, Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance
Note: Fortrea may consider equivalent experience in lieu of educational requirements
Language Requirements:
Speaking: English and local language
Writing/Reading: English and local language
Key Skills:
Strong team player and peer support contributor
Excellent attention to detail
Good verbal and written communication skills
Strong logical, spelling, and numerical proofreading skills
Familiarity with MS Office, Windows, and standard office equipment
Ability to manage multiple tasks and set priorities effectively
Physical Demands / Work Environment:
Office-based or remote work setting, as assigned
May involve use of standard office equipment
Equal Opportunity Statement:
Fortrea is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to:
Race, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Reasonable accommodations will be made for individuals with disabilities throughout the recruitment process.
🔗 Learn more about EEO & Accommodations
How to Apply:
📤 Job ID: 253818
📍 Location: Pune, India
🔗 Apply via Fortrea Careers Portal: www.fortrea.com
About Fortrea:
Fortrea is a leading global Contract Research Organization (CRO) operating in ~100 countries. We provide clinical development and technology solutions across more than 20 therapeutic areas for pharmaceutical, biotechnology, and medical device clients.
We are dedicated to transforming the drug and device development process to bring life-changing therapies to patients faster.
Our Core Values:
Forward Together
Own It
Uphold Integrity
Respect People
Join our mission-driven team and make a meaningful global impact.
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