346681BR
Jun 06, 2022
Chile

Job Description

21,000. That’s how many people Novartis hires globally every year. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?

The people we serve need you to achieve the extraordinary. That's why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.

The POP Governance Manager will help to ensure the local implementation of the Novartis Patient Oriented Programs standards, policies, guidelines and processes and also ensure that the local POP governance is aligned with the Global Governance Office (GGO) and POPs managed by Chile organization meet patient safety and compliance requirements. In addition, this role will assess local risks for Novartis related to POPs and establish risk mitigation plans.

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
-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
-Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases)
-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 actions. Measure efficiency 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.
-Work jointly with other areas (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks.

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

-Health Care Sciences Professional (e.g. Medical Doctor, Pharmacist) or equivalent education, training and experience
-Fluent in both written and spoken English
-Knowledge of national regulations for pharmacovigilance
-Knowledge of patient oriented programs management (preferably)
-Excellent communications, interpersonal and negotiation skills
-Quality and focus oriented
-Computer skills

You’ll receive:
Competitive salary, annual bonus, flexible working arrangements, subsidized dining facilities, employee recognition scheme, professional development, learning experiences, diversity & inclusion.

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
Chile
Región Metropolitana
Research & Development
Full Time
Regular
No
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346681BR

Patient Oriented Programs Governance Manager

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