AstraZeneca Released Job Openings On 09/06/2022.AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do.Application form link provided at the end of post.
Vacancy Details:
AstraZeneca Recruiting Medical graduation/ M.Pharm / M.Sc/ PhD Candidates with 1+ years of Experience for Executive – Regulatory Affairs Position.Complete Details for the Executive – Regulatory Affairs as follows.
Important Details :
- Location :Bangalore/Bengaluru
- No of Vacancies:NA
- Details of Salary:₹ 1,50,000 – 6,50,000 P.A.
- Opening date for online Application:09/06/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
Scope of Work:
Clinical Trial (01):
- Should have experience of working in SUGAM Portal for Global Clinical Trial Application
- Planning, execution, & ensure timely submission of all kinds of Post Approval Changes for Global Clinical Trials and Phase IV studies (Including Protocol /IB Amendment/IMPD/ICF Amendment, Status reports (Quarterly and Six Monthly) Site Addition/Site Closure and other notification (EC approval submission, CTA submission, CTRI registration etc.)
- Preparation and Filing of Test License (TL) application/Additional TL/Renewal of TL application.
- Response to HA Queries
- e-TMF Update
- Maintenance of Regulatory trackers for GCTs
- SAE reporting for Clinical Trials and Phase UV
Pharmacovigilance (02)
- Should have experience of working in SUGAM Portal for SAE Applications
- AE reporting to HA for Marketed products as per Indian regulations
- SAE reporting to Indian HA for GCTs and Phase IV
- PSUR submissions to HA
- Handling of Product Quality Complaint
- Maintenance of all PV trackers and archival
Regulatory Affairs (01)
- Preparation and submission of Post Approval Changes
- Maintenance of Regulatory Trackers
- Ensure compliance of labelling (and mock-ups) with the Company Core Data Sheet
- Review of Labels
- Maintenance of all Regulatory trackers and archival
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