Medical Safety Lead

Major accountabilities:

• Monitors the clinical safety of projects/products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety-related questions appropriately.
• Performs medical assessment and related activities for single 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. Of note: medical review of single case reports may need to be performed by Medical Safety Leads as required according to business needs.
• Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals based on single cases and aggregate data using proper signal detection tools.
• Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues.
• May support the GPSL and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL.
• Prepares medical input to aggregate clinical safety regulatory reports.
• Provides inputs and collaborates on preparation of Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates. Provides guidance as appropriate to Clinical and Pharmacovigilance Operations for the coding and causality/expectedness assessment of adverse event reports. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
• Collaborates 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.
• Provides safety inputs for clinical and regulatory deliverables including clinical study protocols, clinical study reports, and investigator brochure. Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.

Minimum Requirement :

• 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. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.Relevant experience (e.g., clinical, postdoctoral) after graduation.

• At least 4 years in drug development in a major pharmaceutical company, including 2 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.

• Proven 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 and regulatory reports involving safety information • Experience with (safety or others) issue management.

Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s 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’s 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