Safety Science Coordinator I | Pune, India
Company: Fortrea
Location: Pune, Maharashtra, India
Job ID: 26589
Employment Type: Full-Time
Application Deadline: 03 March 2026
Work Model: Office-Based or Remote (as applicable)
About Fortrea
Fortrea is a leading global contract research organization (CRO) providing clinical development and patient access solutions to pharmaceutical, biotechnology, and medical device companies. With strong expertise in pharmacovigilance, clinical operations, and regulatory compliance, Fortrea supports sponsors in delivering safe and effective therapies worldwide.
Job Overview
The Safety Science Coordinator I supports Clinical Safety and Pharmacovigilance (PV) operations, managing adverse event (AE) processes across clinical trial and post-marketing environments. The role involves processing expedited safety reports, maintaining safety databases, ensuring regulatory compliance, and delivering high-quality safety services to internal and external stakeholders.
This position is critical to ensuring accurate, timely, and compliant reporting of safety data to clients, regulatory authorities, ethics committees, and investigators.
Key Responsibilities
Adverse Event Processing and Reporting
Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Manage safety data entry into adverse event tracking systems.
Ensure accurate logging of AE and Serious Adverse Event (SAE) reports.
Draft clear and medically accurate patient narratives.
Code adverse events using MedDRA (for marketed products, where applicable).
Support listedness assessments against approved product labels.
Generate data clarification queries in collaboration with medical staff.
Submit expedited SAE reports within regulatory timelines to clients, regulatory authorities, ethics committees, and partners.
Safety Systems and Compliance
Maintain and update adverse event tracking systems and project documentation files.
Support database reconciliation activities.
Maintain country-specific safety reporting requirement documentation.
Ensure compliance with global pharmacovigilance regulations and company SOPs.
Operate within the Quality Management System (QMS), adhering to Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Prepare safety study files for archiving at project completion.
Quality and Operational Support
Participate in peer and quality reviews of processed safety reports.
Support trend analysis and corrective action implementation.
Provide administrative and coordination support to Pharmacovigilance teams.
Arrange internal and external meetings and teleconferences.
Train and mentor junior safety personnel or peers.
Ensure data accuracy, integrity, and audit readiness.
Regulatory and Safety Compliance
Comply with Health and Safety regulations and applicable European Commission directives.
Ensure pharmacovigilance compliance in line with regulatory authority expectations.
Support safe and cost-effective delivery of safety services.
Educational Qualifications
Candidates must meet one of the following criteria:
Non-degree qualification with 1–2 years of Safety experience or relevant industry experience.
Associate degree with 6 months to 1 year of Safety experience.
Bachelor’s degree (BS/BA) with 0–1 year of Safety or relevant experience.
Master’s degree (MS/MA) with 0–6 months of Safety experience.
PharmD with 0–6 months of Safety experience.
For PharmD candidates, a one-year residency or fellowship may be considered relevant experience.
Preferred academic disciplines:
Biological Sciences
Pharmacy
Nursing
Medical Sciences
Life Sciences
Related healthcare or scientific fields
Fortrea may consider equivalent relevant industry experience in lieu of formal education requirements.
Experience Required
0–2 years of pharmacovigilance or clinical safety experience.
Hands-on experience in AE/SAE case processing, narrative writing, MedDRA coding, and regulatory submissions preferred.
Experience in pharmaceutical, biotechnology, or CRO environments is advantageous.
Exposure to Medical Affairs, Clinical Data Management, Regulatory Affairs, or Quality Assurance is considered relevant.
Key Skills and Competencies
Strong attention to detail and data accuracy.
Ability to manage multiple priorities and meet strict timelines.
Good written and verbal communication skills in English and local language.
Logical reasoning and proofreading skills, particularly with numerical data.
Proficiency in MS Office and Windows-based systems.
Ability to work collaboratively within cross-functional teams.
Strong keyboard and documentation management skills.
Work Environment
Office-based in Pune or remote, depending on project requirements.
Standard office equipment usage.
Collaborative, compliance-driven environment focused on patient safety and regulatory excellence.
Equal Employment Opportunity
Fortrea is committed to diversity, equity, and inclusion. All qualified applicants will receive consideration for employment in accordance with applicable employment laws and regulations.
Explore more global Pharmacovigilance, Clinical Safety, Regulatory Affairs, and CRO job opportunities at ThePharmaDaily.com.
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