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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Pharmacist / Medical Representative |
| EmploymentType | Full-time |
Dear Candidate,Greetings From Golden Opportunities!Job Title:Team Lead Pharmacovigilance Quality ReviewerJD:Have a broad knowledge of case handling processEstablish well-developed customer relationship through Interface OrganizationFeedback errors found in expeditable and non-expeditable cases to team leadersQuality Reviewer can perform post closure quality and process control on closed cases if the task is assigned to him/herQuality Reviewer can perform internal quality check if the task is assigned to him/herQuality Reviewer can complete performance data check and assessment if the task is assigned to him/her.Quality Reviewer can perform compliance data evaluation if the task is assigned to him/herEnsure completion of basic PV training in case handling.Begin and complete the process of training on serious and non-serious cases.Ensure structured data entry of adverse events onto clients global PV safety database according to project specific SOPS and User Manual.Perform quality check before closure of cases where other team member are not signed off on serious cases.Perform all activities within the required timeframes to ensure regulatory complianceAcademic Qualification:Qualified to degree level in biosciences or an appropriate healthcare or pharmaceutical industry background.Drug Safety/Pharmacovigilance experience and an understanding of the international regulatory requirements for single case expedited reporting is an advantage.Technical:An understanding of the principles and concepts associated with Patient Safety case-handling processincluding regulatory requirements for single case expedited reporting and periodic safety update reports.Patient Safety policies,processes and procedures knowledge.Basic competence with medical and therapeutic terminology.
Keyskills :
calibrationpsursinspectionquality assurancepsurmeddrapharmacovigilanceargus safetymedical affairsadverse event reportingcustomer relationse2btechnicalqualityarisgcommonectdelectronicdocument