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Pharmacovigilance Services Sr Analyst

Pharmacovigilance Services Sr Analyst

Accenture

5 - 8 years

4 - 8 Lacs

bengaluru

Posted:23 hours ago| Platform:

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Skills Required

service operations ssas pharmacovigilance ssrs ssis drug safety power bi data warehousing business development t-sql sql server sql client relationship management clinical research case processing meddra clinical trials msbi

Work Mode

Work from Office

Job Type

Full Time

Job Description

About The Role

Skill required: Pharmacovigilance Services - Safety Writing

Designation: Pharmacovigilance Services Sr Analyst

Qualifications:Bachelor of Pharmacy/Master of Pharmacy/BSc. Nursing

Years of Experience:5 to 8 years
Language - Ability:English(Domestic) - Expert

What would you do? Prepare and review RMP/PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents.Perform scheduling of reports, and author, peer review, publishing and tracking activities of assigned reports.Requesting for inputs, literature screening for assigned reports.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.

What are we looking for?

Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts
Qualification Bachelor of Pharmacy,Master of Pharmacy,BSc. Nursing

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Pharmacovigilance Services Sr Analyst