GSS Pharma Private Limited
- Downloading literature reports, line listing and case processing of the same.
- Accountable for reviewing and assessing 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 about current updates and regular activities.
- Assuring compliance with the use of database through reference of latest SOPs and relevant manuals.
- Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive work flow 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 labelling documents and other aspects of Drug Safety.
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