GSS Pharma Hiring for Pharmacovigilance Associate at Bengaluru, Karnataka, India Full Time

Job Description

PHARMACOVIGILANCE – JOB DESCRIPTION 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 for serious adverse events (SAE). Extended Eudravigilance Medical Product Dictionary (XEVMPD) maintenance and EVWEB updates including Summary of Product Characteristics (SPC/SmPC), Packaging Insert Leaflet (PIL) inserts, and updations. European Union Reference Dates (EURD)/work-sharing list to be downloaded and PSUR schedule to be updated immediately. Preparation of Risk Management Plan (RMP) according to the standards, evaluation, and submission. Preparation of PSUR/PBRER according to the standards, evaluation, and submission. Vigilance on Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and updating the same. Worldwide scientific Literature Management which includes screening and processing of Literature reports. Regular meeting with clients, discussing current updates and regular activities. 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. Responsible for ensuring that the individual training records are updated in line with inspection readiness. Representing Drug Safety in regulatory and internal inspections and audits as required. Developing and maintaining knowledge of the appropriate disease biology areas. Responsible for developing a collaboration with relevant Drug Safety Personnel for maintaining awareness of critical Adverse Events, knowledge of labeling documents, and other aspects of Drug Safety.Expected Start Date: 7/2/2022Job Types: Full-time, Regular / PermanentSalary: INR250,000.00 – INR300,000.00 per yearBenefits:

• Health insurance

Schedule:

• Day shift

Supplemental Pay:

• Yearly bonus

Experience:

• Health & Medical Researchers: 1 year (Preferred)
• total work: 1 year (Preferred)

Work Remotely:

• No