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Drug Safety Associate
1 week ago
About the Role of Drug Safety Associate at GSS Pharma Pvt.Ltd
GSS Pharma Pvt.Ltd, a leading pharmaceutical company located in Bangalore, India, specializes in manufacturing and exporting finished formulations across various therapeutic segments, including psychotropic and controlled substances. The company is dedicated to providing high-quality products and services and is supported by a team of dedicated professionals. Additionally, GSS Pharma offers Pharmacovigilance services to pharmaceutical companies globally.
Responsibilities of Drug Safety Associate:
- Thorough understanding of current global pharmacovigilance guidelines and procedures
- Prioritize cases based on urgency and severity, ensuring timely completion as per client SOP
- Verify data accuracy captured by case registration/import associate
- Perform duplicate checks during case processing to identify inconsistencies
- Download literature reports, line listings, and process cases accordingly
- Review and assess the validity of literature abstracts and articles before database entry
- Download and process Individual Case Study Reports (ICSR)
- Conduct MedDRA coding
- Stay updated on Pharmacovigilance Risk Assessment Committee (PRAC) recommendations
- Manage worldwide scientific literature including screening and processing reports
- Ensure compliance with database usage through the latest SOPs and manuals
- Maintain compliance with regulatory timelines through proactive workflow management
- Represent Drug Safety in regulatory and internal inspections and audits
Qualifications:
- Proficiency in Narrative, Medical Coding, and Pharmacy skills
- Holder of a Doctorate in Pharmacy (Pharm D)
- High attention to detail
- Familiarity with pharmacovigilance regulations and requirements
- Excellent written and verbal communication abilities
- Experience in Pharmacovigilance or related roles is advantageous
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