Job ID
364946BR

Feb 22, 2023

India

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\xe2\x80\x99s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.

Your responsibilities include, but are not limited to:

• Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
• Archiving all safety documentation as per respective policies, guidance, and procedures. Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updates
• Verification and update of respective PS archiving system (incl. review, update, management); Monitoring of the compliance. Support in organizing response to queries from Countries and regions and other functions outside medical safety
• Support in developing, updating, and implementing global procedures to ensure compliance. Management and maintenance of relevant Global PS databases/sharepoint.
• Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to HA, development and implementation of corrective action(s) as needed.
• Preparing metrics as required and agreed with the manager. Support the Group Head, Medical Safety Operations/Medical Safety Group Lead/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA in day to day operations as per assigned responsibilities
• Support Literature review for PSUR inclusion and assessment of literature for signals. Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA
• Support in preparation of responses to internal safety requests and contribute to responses to external safety queries

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

• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate.
• 1-2 years in patient safety. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries
• Good understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology. Attention to detail and quality focused
• Good communication skills, and the ability to operate effectively in an international environment
• Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process
• Good presentation skills; Good computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s 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


Division
Novartis Technical Operations
Business Unit
NTO SANDOZ TECHOPS
Location
India
Site
Hyderabad, AP
Company / Legal Entity
Sdz Pvt Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No