Global Program Safety Lead - Oncology (80-100%)

Basel
24 January | Position with re­spon­si­bil­i­ties | 80 – 100%

Global Program Safety Lead - Oncology (80-100%)

Job ID 336846BR Jan 21, 2022 Switzerland

Job Description

More than 52 different medical diseases! Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative immuno-oncology medicines.

As our Global Program Safety Lead within Oncology you will provide scientific and strategic leadership to optimize benefit-risk for assigned compounds.

You will ensure optimal patient safety and will be responsible for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.

Your responsibilities will include, but are not limited to:

• Design and develop safety surveillance strategy for products in the development and post-approval.
• Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
• Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Support and guide compliance with governmental regulations on Good Pharmacovigilance Practice.
• Provide and contribute trending and safety signal detection and risk management assessment for the products’ life cycle.
• Provide safety support to the clinical development teams.
• Lead the preparation of the safety strategy for health authority responses, in collaboration with other project team members
• Provides 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)

• Some restrictions to flexible working models may apply and will be discussed at interview if relevant

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

What you’ll bring to the role:

• MD preferred (PhD, PharmD)
• Proficiency English (oral and written)
• 3-4 years relevant experience Medical Safety, Benefit/Risk Evaluation, Epidemiology Post Authorization, Data SafetyDivision Global Drug Development Business Unit CMO & PATIENT SAFETY GDD Location Switzerland Site Basel Company / Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account