Data Analyst Level 1
Certara
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Job Description
 Location: Pune, India
Employment Type: Full-Time
Posted On: Today
Application Deadline: October 11, 2025 (13 hours left to apply)
Job Requisition ID: 255120
Introduction
Fortrea is seeking a Safety Science Coordinator I to support Clinical Safety and Post-Safety Surveillance (PSS) operations associated with medical products. This role involves managing the entire adverse events process, including safety data from clinical trials and post-marketing sources (unsolicited reports).
You will be responsible for processing expedited adverse events to required standards and submitting them to clients and regulatory agencies within agreed timelines. This position may function as a support role to client project groups or as a stand-alone service. Compliance with all applicable legal and safety requirements, including the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3, is expected.
Role & Responsibilities
- Assist in the processing of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) and their submissions.
- Maintain adverse event tracking systems and set up project and central documentation files.
- Report ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel within study timelines.
- Ensure all incoming Adverse Event (AE) / Serious Adverse Event (SAE) reports are logged and forwarded appropriately.
- Perform data entry of safety data into tracking systems.
- Write patient narratives and code adverse events using MedDRA (for marketed products, if applicable).
- Conduct listedness assessments against product labels (for marketed products, if applicable).
- Generate queries for missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to relevant stakeholders within agreed timelines.
- Assist with peer/quality review, database reconciliation, and trend/action reporting.
- Maintain files for adverse event reporting requirements across countries.
Educational Qualification
- Non-Degree: 1–2 years of Safety or relevant experience.
- Associate Degree: 6 months–1 year of Safety or relevant experience.
- BS/BA: 0–6 months to 1 year of Safety or relevant experience.
- MS/MA: 0–6 months of Safety experience or relevant experience.
- PharmD: 0–6 months of Safety experience or one-year residency/fellowship.
- Preferred Disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
- Safety Experience: Processing AE/SAE reports, writing narratives, generating queries, working with safety databases, regulatory submissions.
- Relevant Experience: Pharmaceutical, biotechnology, or CRO industry experience in Medical Affairs, Clinical Data Entry/Management, Monitoring, Regulatory Affairs, or Quality Assurance.
- Language: Proficiency in English and local language (speaking, reading, writing).
Location
 Pune, India
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