Global Program Safety Lead

Novartis Pharmaceuticals   •  

East Hanover, NJ

Industry: Pharmaceuticals & Biotech


Less than 5 years

Posted 27 days ago

Job Description

817 million. That's how many lives our products touched in 2018. And while we're proud of that, 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:

 Successfully serves as a safety leader of the Chief Medical Office and Patient Safety organization to improve patients' lives and impact on overall Novartis results through robust safety evaluation, medical expertise, and innovation.

 Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).

 Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.

 Chair and lead Safety Management Team meetings, and network within GPT LFs and CMO-PS.

 Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required (e.g., when significant new information received). Ensures that these, and all other project-related safety documents, are consistent in safety messages.

 Own the safety strategies and ensure proper documentation (e.g., dSPP, SSPT) and lead the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products

 Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team (SMT). Ensures that this team appropriately and timely reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process.

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

What you will bring to the role:

 Medical Degree (preferred) or equivalent graduate level of a health care professional degree is required, and/or Specialty Board certification, desirable but not required.

 3 years clinical experience postdoctoral or equivalent medical practice.

 At least 5 years in drug development (of which 2 years in a global position), including 3 years in safety at an operational or medical position preferred

 Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information or safety data

 Experience in leading cross-functional, multi-cultural teams

 Experience with issue management (safety, risk management, HA responses, others)

 Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and medical writing (publications or aggregate safety reporting), preferred

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.