Biological E Limited Hiring For QA Pharmacovigilance
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| Biological E Limited Hiring For QA Pharmacovigilance |
Biological E Limited Job Vacancy Details:
Biological E. Limited is hiring for QA Pharmacovigilance, Pharma SGI - USFDA Approved plant, Shamirpet location, Hyderabad.Position: Executive/ Senior Executive
Qualification: B.Pharmacy/ M.Pharmacy
Experience: 4 to 9 years
Job Description:
* Responsible to monitor the pharmacovigilance activities as per the SOPs.
* To coordinate with the third party pharmacovigilance services to obtain the Medical Information Call Center(MICC) reports, Medical literature monitoring(MLM) reports, Individual Case Safety Reports(CSR) and Drafts Periodic Adverse Drug Event Reports(PADER).
* Responsible for Preparation, Review and maintain the Safety Data Exchange Agreements(SDEA).
* Responsible for Review of Individual Case Safety Reports ICSR).
* To ensure that all the Pharmacovigilance activities were completed and reported in
timely manner.
* Responsible to Review and maintain the Medical literature monitoring(MLM) schedule and Periodic Adverse Drug Event Reports(PADER) calendar.
* Responsible for Handling of market complaints, Investigations and Proposing appropriate CAPAS Accordingly.
* Preparation and review of Standard Operating Procedures (SOP).
* Responsible for the preparation of market complaints Trends as per the SOP requirements.
* Preparation of ADE summary reports as applicable (Adverse Event).
*Responsible for initiation of Change Controls, Deviations and CAPAS.
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