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Aggregate Report Manager

Employer
Novartis
Location
Hyderabad, India
Salary
Competitive
Closing date
Feb 9, 2023

View more

Discipline
Other
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma

Job Details

Job Description

500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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.

Your responsibilities include, but are not limited to:

• Responsible for monitoring of global compliance, quality, efficiency and management of aggregate safety analysis/ reports for products across Sandoz Group Portfolio.
• Ensure development and maintenance of processes for inhouse and outsourced activities related to Aggregate Report management in collaboration with Medical Safety and other functions to meet global Aggregate Reporting regulatory requirements.
• Author, review and update SOPs related to Aggregate Reports (if assigned). Interact with strategic supplier to review their performance and identify areas of development for capability building
• Lead global internal audits and Health Authority Inspections taking complete responsibility for inspection readiness and timely implementation of necessary corrective and preventive actions.
• Lead Aggregate reporting related workstreams and act as subject matter expert for cross functional projects including strategic Novartis acquisitions and mergers
• Represent Patient Safety at internal and external meetings with global line-functions and third party (eg. Vigilance Agreement Partners)
• Drive operational excellence to optimize business efficiency in alignment with Patient Safety’s objectives and vision
• Responsible for assuring conformity with global procedures, process, and regulatory requirements for all associates of aggregate team within Sandoz and strategic suppliers.

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

• Six years of pharmaceutical industry experience, preferably pharmacovigilance.
• Knowledge of drug safety regulatory requirements and general project management including at least three years in Aggregate reports experience is desirable.
• Two years of people management and development experience is desirable.
• 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.

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 do here at Sandoz!Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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Company

At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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