Novartis Vigilance Quality Excellence Expert Vacancy – Apply Online
Novartis hiring a Vigilance Quality Excellence Expert. This is the exposure and scale our Data Management group has. They are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data that is fit for purpose.Check out all the details
Job Title: Vigilance Quality Excellence Expert
Job Id: 331562BR
Eligibility Criteria:Â
• PharmD, MSc degree in life sciences or equivalent.
• Fluency in English. Knowledge of other languages is desirable.
• 2 to 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance is 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
Your responsibilities include, but are not limited to:
• Lead projects to enhance the methodologies and processes used to monitor and improve safety cases 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 the accuracy and completeness.• 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 the 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 the 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 the scope of responsibilities; triage emails and respond/ forward queries as appropriate.
• Perform reconciliation of safety information exchanged with global license partners to confirm the completeness, the investigation into any gaps identified, and the 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.
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