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Safety Writer - Aggregate Reports (AR)

Employer
Novartis
Location
Hyderabad, India
Salary
Competitive
Closing date
Dec 31, 2022

View more

Discipline
Other
Position Type
Full Time
Organization Type
Pharma

Job Details

Job Description

2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.

Your responsibilities include, but are not limited to:

• Support/lead end-to-end preparation of aggregate safety reports. Support coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
• Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
• Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.
• Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
• Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards. Adhere to good documentation practices to ensure audit/inspection readiness.
• Support projects related to operational excellence (including testing of safety systems/IT application) and process improvements according to internal and externals drivers
• Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings. Responsible to be informed with the current global PV regulatory requirements.

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

• Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages desirable.
• 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
• Preferably, at least 2 years of experience in safety/ medical/scientific/regulatory writing
• Excellent understanding of drug development process, GCP and medical terminology
• Strong negotiation and communication skills, and ability to operate effectively in an global environment and across line functions
• Strong organizational and project management skills, with an ability to lead work groups.

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.
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 .

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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