Senior Medical Safety Lead

Job ID 344150BR

Your responsibilities include, but are not limited to:

• 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. May deputize for the GPSL (in agreement with the project’s GPSL) or function as a GPSL for products to which no GPSL are assigned.
• Performs medical assessment and related activities for single cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, literature review 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 Senior 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 input to responses for legal queries and Country Organization requests involving safety issues.
• Provides pharmacovigilance inputs to initial development and subsequent updates of core data sheet (CDS) and its related documents. May review and author submission documents (e.g. summary of clinical safety, clinical overview).
• Plays a significant role in the development and maintenance of Safety Profiling Plans (SPP) and Risk
• Management Plans (RMP) including the coordination with other line functions for associated activities such as updates, and the ongoing tracking of commitments and effectiveness measures.
• Provides guidance as appropriate to Clinical/PV Safety Operations for the coding and causality/expectedness assessment of adverse event reports.

Minimum requirements

• Medical Degree (MBBS or MD) required. 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 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.
• 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/submissions involving safety information.
• Experience with (safety or others) issue management.

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Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.