343903BR
May 02, 2022
USA

Job Description

766 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

In close collaboration with the Global Program Safety Lead (GPSL), you will provide robust safety evaluation expertise and medical innovation in order to improve patients’ lives and impact on overall Novartis results. As a member of the Medical Safety organization, you will prioritize the safety of patients, ensure optimal patient safety for assigned compounds and share responsibility for the integration and analysis of internal and external safety information through product lifecycle management. You may also deputize partial or full responsibilities of the GPSL.

*Role(s) will be filled at level commensurate with experience and in the following locations: United States, Europe (Switzerland, Spain), India and United Kingdom. Successful candidate(s) will be hired in local area of application*


Your responsibilities will include, but are not limited to:

• Monitor the clinical safety of projects/products both marketed and in clinical trials
• Perform medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases and preparation of investigator notifications and periodic medical assessments for ethics committees.
• Perform signal detection, monitoring and evaluation of all safety signals
• Provide inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Prepare safety data for Health Authority review boards.
• Provide inputs to responses for legal queries and Country Organization requests involving safety issues.
• Provide expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
• Collaborate productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:
• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred.
• Fluent in spoken and written English
• At least 6 years in drug development in a major pharmaceutical company, including 4 years in patient safety at an operational or medical position (or equivalent experience) is desirable
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
• Confirmed ability to analyze, interpret, discuss, and present safety information both in writing and orally
• Experience in preparing or contributing to preparation of clinical safety assessments
• Experience with (safety or others) issue management.

Why consider Novartis?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the

Novartis Network here:
https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
CMO & PATIENT SAFETY GDD
USA
East Hanover, NJ
Switzerland
India
Spain
Research & Development
Full Time
Regular
No
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343903BR

Medical Safety Lead/Sr. Medical Safety Lead (Multiple TAs)

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