Intas Released Job Openings On 02/07/2022.Intas Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors..Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Intas Recruitment 2021 are provided below. Interested and eligible candidates can submit application along with resume.Â
Vacancy Details:
Intas Recruiting M.Pharma candidates with 00 -02 Years Experience for EXECUTIVE PMQA- CRO Position.Complete Details for the EXECUTIVE PMQA- CRO as follows.
Important Details :
- Location :Ahmedabad
- No of Vacancies: NA
- Details of Salary:NA
- Opening date for online Application: 02/07/2022
- 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
Related Job: Aurobindo pharma Walk In Interview On 5th July 2022Â
Job Description/Skills Required
Responsible for reporting of any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials to service provider CRO.
1. Direct PMQA Responsibility
- Responsible for quality review of Pharmacovigilance Document (i.e. PSUR, RMP & SDEA)
- Responsible for handling of post marketing complaint of biotech products
- Reconciliation of Product market complaint with respective client & vendor
- Responsible for preparation, timely updation and management of all SDEA for all clients
- Review of CRO monitoring report of late phase studies in compliance with regulatory requirement and as per approved clinical study protocol for all assigned projects.
- Work with CRO colleagues, to implement, review and maintain tracking of incidents within the trials, advising on CAPAs to be implemented and ensure completion in a timely manner for assigned studies
- Assist to team for Management of clinical trial in terms of project hygiene for assigned projects
- Preparation of Sponsor clinical study file as per ICH-GCP E6 requirement for assigned projects
- Assist to team for IMP Management for assigned projects
- Management documents pertaining to clinical study and Pharmacovigilance.
- Coordination with respective stake holder for smooth functioning
- Undertake any other work that may be reasonably required from time to time.
- Undertake work in accordance with INTAS policies and values.
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