Drug Safety Associate

3 weeks ago


Bengaluru, India GSS Pharma Pvt.Ltd Full time

Company Description
GSS Pharma Pvt.Ltd is an emerging pharmaceutical company based in Bangalore, India. With a focus on manufacturing and exporting finished formulations, GSS Pharma caters to a diversified pharmaceutical market with over 400 formulations in therapeutic segments, including psychotropic and controlled substances. Committed to delivering quality products and services, GSS Pharma has a professionally managed team of passionate individuals. The company also offers Pharmacovigilance services to pharmaceutical companies worldwide.

Role Description
This is a full-time on-site role for a Drug Safety Associate at GSS Pharma Pvt.Ltd in Bangalore Urban. The Drug Safety Associate will be responsible for tasks related to Pharmacovigilance, including assistance to QPPV, global literature monitoring, data entry and quality review, signal detection and evaluation, and preparation of regulatory documents.

Detailed knowledge about current global pharmacovigilance guidelines and procedures
•            Prioritize the cases according to day zero and seriousness, and ensure the cases are completed according to the timelines mentioned in client SOP.
•            Verifies the data captured by case registration/import associate for accuracy.
•            Performs duplicate check during case processing to identify any inconsistency as applicable.
•            Downloading literature reports, line listing, and case processing of the same.
•            Accountable for reviewing and assessing the validity of literature abstracts and articles with further processing onto the safety database if required.
•            Downloading Individual Case Study Reports (ICSR), line listing, and case processing of the same.
•            MedDRA coding.
•            Vigilance on Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and updating the same.
•            Worldwide scientific Literature Management which includes screening and processing of Literature reports.
•            Assuring compliance with the use of database through the reference of latest SOPs and relevant manuals.
•            Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management.
•            Representing Drug Safety in regulatory and internal inspections and audits as required.

Qualifications
Narrative, Medical Coding, and Pharmacy skills
Doctor in Pharmacy (Pharm D)
Excellent attention to detail
Knowledge of pharmacovigilance regulations and requirements
Strong written and verbal communication skills
Experience in Pharmacovigilance or related role is a plus


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