Safety Writer - Hyderabad, Telangana, India - Novartis

Novartis

Verified Company

Hyderabad, Telangana, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

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 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.

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._

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.

Division
Global Drug Development

Business Unit
CMO & PATIENT SAFETY GDD

Country
India

Work Location
Hyderabad, AP

Company/Legal Entity
Nov Hltcr Shared Services Ind

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No