Position Name: Drug Safety Associate
Organization: GSS Pharma Pvt. Ltd.
Location: Bangalore Urban, India
About GSS Pharma:
GSS Pharma Pvt. Ltd. is an emerging pharmaceutical company based in Bangalore, India. Specializing in manufacturing and exporting finished formulations, GSS Pharma offers over 400 formulations across various therapeutic segments, including psychotropic and controlled substances. The company is committed to delivering quality products and services with a team of passionate and professionally managed individuals. GSS Pharma also provides Pharmacovigilance services to pharmaceutical companies globally.
Qualifications:
- Pharm D
Experience:
- Experience in Pharmacovigilance or a related role is a plus
Key Responsibilities:
| Responsibility Category | Details |
|---|---|
| Global Literature Monitoring | Conduct literature reviews and process reports into the safety database. |
| Data Management | Perform data entry, quality reviews, and ensure accuracy in case processing. |
| Signal Detection and Evaluation | Engage in signal detection, evaluation, and MedDRA coding. |
| Regulatory Documentation | Prepare and manage regulatory documents and ensure compliance with SOP timelines. |
| Risk Assessment and Monitoring | Monitor PRAC recommendations and manage scientific literature screening and processing. |
| Inspection and Audits | Represent Drug Safety in regulatory and internal inspections and audits. |
Skills and Competencies:
- Proficiency in Narrative, Medical Coding, and Pharmacy skills
- Strong knowledge of Pharmacovigilance regulations and requirements
- Excellent attention to detail
- Superior written and verbal communication skills
Apply Online:
[Link to Application]
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Join our team at GSS Pharma and contribute to global Pharmacovigilance efforts! 🌟