PV Capability Compliance & Risk Analyst

Job Description

“2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!”

PV Capability Compliance & Risk Analyst is accountable for developing, implementing, and performing monitoring activities designed to ensure compliance in accordance to Sandoz internal and worldwide regulatory timelines.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Support review of emerging worldwide regulations, performing impact assessments and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Contribute to projects aimed at optimizing metrics methodologies and processes to monitor risk and compliance.
• Act as the business function responsible for allocated quality issues and quality events, supporting CMO&PS throughout the quality issue management process.
• Lead projects related to Safety Systems/AQWA/1QEM/CAPA applications including contributing to testing activities.
• Work closely with Quality Assurance (QA) and process owners to perform investigations and develop appropriate CAPAs and effectiveness checks.
• Ensure that any risks identified through metrics data analysis and reports and are escalated in a timely manner.
• 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.
• Alert Director Process Governance, Compliance and Risk manager of potential compliance issues

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

What you’ll bring to the role:

• Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree with ≥ Two years of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development.
• Ability to lead and deliver cross divisional initiatives.
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
• Excellent planning, organizational and computer skills.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 achieve here at Sandoz!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Group 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