347318BR
Jun 20, 2022
India

Job Description

350+ metric reports generated annually! Compliance and Quality Managers are part of global Operational Excellence team, working to develop metrics standards and ICSR data entry standards for Chief Medical Office and Patient Safety (CMO&PS), 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. From a collaborative effort with Pharmacovigilance Operations and Medical function, we analyze tons of data, deriving relevant insights and lead projects to enable continuous improvement in compliance and quality of CMO&PS deliverables.

Your responsibilities include, but are not limited to:

• End to end management of assigned pharmacovigilance processes across Novartis Divisions. Responsible for ensuring compliance to global regulatory requirements with maximum efficiency -Lead assigned cross functional patient safety projects
• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally
• Develop and maintain training material and communications for Novartis group and third party associates Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements
• Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases). Analyze the impact of other process and organizational changes
• Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
• Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks. Mentor and train new starters.

Diversity & Inclusion / EEO

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

Minimum Requirements

• Operations Management and Execution
• Project Management
• Collaborating across boundaries
• Functional Breadth
• People Challenges
• Managing Crises

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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347318BR

Vigilance Quality Excellence Manager(Pharmacovigilance)

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