About the Company :
About the Job:
Job location: Bangalore
1. PV Compliance monitoring associate:
Job responsibilities:
-To conduct and run routine monitoring reports and their analysis related to: ICSR, periodic reports and CAPAs.
- To review, assess and approve CAPAs and deviations for their accuracy and completeness. etc
2. PV Associate I (System specialist):
The ideal candidate needs to have extensive data processing experience in addition to experience in one/more of the following topics:
· End user support
· System Validation
· System Administrator understanding/hands on experience
· Active participation in audits and audit findings reply
· SQL
· Database architecture understanding
· Able to provide training
3. PV Associate II ( PSMF):
Role requirement:
Key user for Electronic document management system (EDMS):
- Managing user rights, supporting users in their daily work
- Providing training to users to improve and promote EMDS use
- Coordination of pharmacovigilance written procedures in EDMS
Maintenance of the Pharmacovigilance System Master File (PSMF):
- Interaction with different global teams to ensure the PSMF is up-to-date
- Ensuring regular updates according to the PSMF maintenance schedule
- Ensuring PSMF is ready promptly when requested by inspectors
At least 3-5 years of experience in Pharmacovigilance, preferably in quality assurance activities (written procedures, deviations, PSMF).
4. PV Agreements Associate:
Initiate, develop and negotiate PV Agreements (PVAs) based on existing templates
Review and update PVAs as necessary
Update PVA templates and procedures
Train and advise local safety officers in negotiating local PVAs and any other PVA related issues
Maintain and update the PV Agreements Management System
Handling and answering inquiries (of partners or internal interfaces) received in the common mailbox
Screening of databases/reports for daily work or periodically (e.g. Regulatory Affairs database, Supply Chain report)
Candidate Requirements:
Any lifescience graduate, preferably with PV / PV Agreements experience
5. PV Associate II:
Member of the Global PhV Agreements Team
Initiate, develop and negotiate PV Agreements (PVAs) based on existing templates
Review and update PVAs as necessary
Update PVA templates and procedures
Train and advise local safety officers in negotiating local PVAs and any other PVA related issues
Maintain and update the PV Agreements Management System
Handling and answering inquiries (of partners or internal interfaces) received in the common mailbox
Screening of databases/reports for daily work or periodically (e.g. Regulatory Affairs database, Supply Chain report)
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