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.

The original job offer can be found in Kit Job:
https://www.kitjob.in/job/22358133/sy-990-associate-bangalore-rural/?utm_source=html

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