| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Lead projects to enhance the methodologies and processes used to monitor and improve safety case and aggregate report quality. Lead the preparation and maintenance of manuals and other documents related to quality monitoring. Ensure safety cases and aggregate reports meet global Health Authority requirements and Novartis quality standards by- Leading quality sampling activities; Performing regular calibration activities; Resolving issues/queries and; Reviewing assigned aggregate reports and/or safety cases to confirm accurate and complete. Managing the online/offline Quality Check (QC) portfolios; Working with process owners and safety system experts to identify and implement new checks required in the Novartis safety database in response to process changes and overseeing timely completion of corrections. Performing follow up monitoring activities including those related to drug exposure during pregnancy. Performing trend analyses of the results of quality sampling, online/offline QC checks and monitoring activities. Leading investigations into the root cause of any deficiencies seen through trend analysis. Collaborating with process owners and other subject matter experts (SMEs) to develop and implement corrective and preventative actions (CAPAs) and, post implementation, verify the effectiveness of these. Preparing reports / presentations on aggregate report and/or safety case quality for CMO&PS management; Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally. Be involved in creation and maintenance of training material and communications for Novartis group and third-party associates. Contribute to projects aimed at optimizing methodologies and processes to monitor safety cases and aggregate reports quality. Manage mailboxes in scope of responsibilities; triage emails and respond/ forward queries as appropriate. Perform reconciliation of safety information exchanged with global license partners to confirm completeness, investigation into any gaps identified and completion of remedial actions. Act as a subject matter expert during inspections (e.g., FDA and EMA) and audits and support with post audit/inspection activities including drafting of responses to any findings and the implementation of CAPAs. Train and mentor new CMO&PS associates and associates from other global line functions.EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable. 2 to 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable. Procedural document/ report writing experience Good analytical skills / proven ability to work with data Good communication and presentation skills Good organizational skills; Ability to mentor and coach,
Keyskills :
subject matter expertsprocess improvement initiativesroot causesafety casemusic makinglife sciencesquality checkglobal healthstatements of work sow