SY-990 | PV Associate

SY-990 | PV Associate

29 Apr
GSS Pharma Private Limited
Bangalore Rural

29 Apr

GSS Pharma Private Limited

Bangalore Rural

- 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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