Associate – Regulatory Affairs
CLINCHOICE
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Safety Science Coordinator I
Full Time | Entry-Level | Office/Remote Option
Location: Pune, India
 Job ID: 255152
Posted: Today
End Date: October 31, 2025
About the Role
This position is ideal for candidates passionate about pharmacovigilance, clinical data management, and regulatory safety compliance—offering hands-on exposure to real-world safety operations within a global clinical research organization.
Role & Responsibilities
- Assist in the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems, ensuring accuracy and completeness of records.
- Support project setup and documentation, including creation of central study files and reporting templates.
- Log and manage incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports in departmental systems.
- Perform data entry of safety data and ensure accurate MedDRA coding of adverse events.
- Write patient narratives and assist in listedness assessments for marketed products.
- Generate and track queries to collect missing or discrepant information.
Educational Qualification
- Education:
- Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, Medical Sciences, or a related field.
- Advanced degrees (MS/MA/PharmD) preferred.
- Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, Medical Sciences, or a related field.
- Experience:
- 0–2 years of experience in Safety Operations, Pharmacovigilance, or Clinical Research.
- Experience with AE/SAE processing, narrative writing, MedDRA coding, and safety database management preferred.
- 0–2 years of experience in Safety Operations, Pharmacovigilance, or Clinical Research.
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Location
 Pune, India
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