Vigilance Quality Excellence Expert

2 weeks ago

Hyderabad, Telangana, India Novartis Full time

100+ process improvement initiatives in Operational Excellence We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, supporting the organizational strategy while striving for an enhanced productivity, quality and better patient outcomes.


Your responsibilities include, but are not limited to:

  • 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.
  • 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.

Commitment to Diversity & Inclusion:

  • We are 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

WHY NOVARTIS


769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.


We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.

And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.

Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis

Commitment to Diversity & Inclusion:


Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


Division
Global Drug Development

Business Unit
Patient Safety & Pharmacovigilance

Country
India

Work Location
Hyderabad, AP

Company/Legal Entity
Nov Hltcr Shared Services Ind

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No

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