Senior Medical Safety Lead

Novartis Pharmaceuticals   •  

East Hanover, NJ

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 23 days ago

Job Description

750 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?

Your responsibilities include, but not limited to:

 Monitors the clinical safety for assigned compounds including signal detection, and evaluation of internal and external safety information through product lifecycle management. May deputize for Global Program Safety Leader including chairing Safety Management Team meetings

 Development and maintenance of Risk Management Plans (RMP) and major contributor/leader of PSURs, DSURs, and Special Assessment Reports

 Provides clinical safety and risk management input to clinical study protocols, clinical study reports, investigator brochure, and submission documents.

 Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.

 Prepares safety data for presentation to internal Novartis boards and Health Authority review boards.

 Provides pharmacovigilance inputs to initial development and subsequent updates of core data sheet (CDS) and its related documents. Contribution and/or authorship of submission documents as required.

EEO Statement

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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required. MD strongly preferred.

 At least 6 years of experience in pharmacovigilance and risk management, including clinical development in a major pharmaceutical company is desirable

 Solid knowledge of global regulations and guidelines associated to clinical safety

 Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally

 Capable to work independently and lead the evaluation of complex safety issues including writing safety summaries and aggregated safety reports

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.

We are Novartis. Join us and help reimagine medicine.