Company: GSS Pharma Pvt. Ltd.
Location: Bangalore Urban, India
Role Description:
GSS Pharma Pvt. Ltd. is seeking a full-time, on-site Drug Safety Associate in Bangalore Urban. The successful candidate will be responsible for various Pharmacovigilance activities, including assisting the Qualified Person for Pharmacovigilance (QPPV), conducting global literature monitoring, and preparing regulatory documents.
Key Responsibilities:
- Assist the Qualified Person for Pharmacovigilance (QPPV)
- Conduct global literature monitoring
- Perform data entry and quality reviews
- Engage in signal detection and evaluation
- Prepare regulatory documents
Specific Duties:
| Task | Description |
|---|---|
| Prioritize Cases | Based on day zero and seriousness, ensuring timely completion as per client SOPs |
| Data Verification | Verify data accuracy captured by case registration/import associates |
| Duplicate Checks | Perform duplicate checks during case processing to identify inconsistencies |
| Literature Processing | Download and process literature reports and line listings |
| Literature Assessment | Review and assess the validity of literature abstracts and articles, processing them into the safety database as required |
| ICSR Processing | Download and process Individual Case Study Reports (ICSR) and line listings |
| MedDRA Coding | Conduct MedDRA coding |
| PRAC Monitoring | Monitor Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and implement updates |
| Scientific Literature Management | Manage worldwide scientific literature, including screening and processing reports |
| Regulatory Compliance | Ensure compliance with regulatory and local/global SOP timelines through proactive workflow management |
| Representation | Represent Drug Safety in regulatory and internal inspections and audits as needed |
Qualifications:
- Doctor of Pharmacy (Pharm D)
- Proficiency in Narrative, Medical Coding, and Pharmacy skills
- Excellent attention to detail
- Strong knowledge of Pharmacovigilance regulations and requirements
- Superior written and verbal communication skills
- Experience in Pharmacovigilance or a related role is a plus
About GSS Pharma Pvt. Ltd.:
GSS Pharma Pvt. Ltd. is an emerging pharmaceutical company based in Bangalore, India. Specializing in manufacturing and exporting finished formulations, the company offers over 400 formulations across various therapeutic segments, including psychotropic and controlled substances. Committed to delivering quality products and services, GSS Pharma also provides Pharmacovigilance services to pharmaceutical companies globally.