GSS Pharma is hiring at Bangalore Urban for a Drug Safety Associate (Pharmacovigilance).
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. Committed to delivering quality products and services, the company boasts a team of passionate and professionally managed individuals. GSS Pharma also provides Pharmacovigilance services to pharmaceutical companies globally.
Position Name : Pharmacovigilance
Organization : GSS Pharma Pvt.Ltd
Qualification: Pharm D
Experience: Experience in Pharmacovigilance or a related role is a plus
Salary: Location:
Bangalore Urban, India
Job Title: Drug Safety Associate
Company: GSS Pharma Pvt. Ltd.
Location: Bangalore Urban, India
Role Description:
We are seeking a full-time, on-site Drug Safety Associate to join our team at GSS Pharma Pvt. Ltd. in Bangalore Urban. The Drug Safety Associate will be responsible for various Pharmacovigilance activities, including:
- Assisting the Qualified Person for Pharmacovigilance (QPPV)
- Conducting global literature monitoring
- Performing data entry and quality reviews
- Engaging in signal detection and evaluation
- Preparing regulatory documents
Key Responsibilities:
- Thorough understanding of current global Pharmacovigilance guidelines and procedures
- Prioritizing cases based on day zero and seriousness, ensuring timely completion as per client SOPs
- Verifying data accuracy captured by case registration/import associates
- Performing duplicate checks during case processing to identify inconsistencies
- Downloading and processing literature reports and line listings
- Reviewing and assessing the validity of literature abstracts and articles, processing them into the safety database as required
- Downloading and processing Individual Case Study Reports (ICSR) and line listings
- Conducting MedDRA coding
- Monitoring Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and implementing updates
- Managing worldwide scientific literature, including screening and processing reports
- Ensuring compliance with regulatory and local/global SOP timelines through proactive workflow management
- Representing Drug Safety in regulatory and internal inspections and audits as needed
Qualifications:
- Proficiency in Narrative, Medical Coding, and Pharmacy skills
- Doctor of Pharmacy (Pharm D)
- 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
Apply here
https://chat.whatsapp.com/DO9PMPj2H3K4SikyHri52x
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