Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Medical Safety Lead
1. 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.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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.
7. Provides guidance as appropriate to Clinical/PV Safety Operations for the coding and causality/expectedness assessment of adverse event reports.
8. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
9. 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
• 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 Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) preferred
• 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
Experience : 4 year
Qualification : B.Pharm, B.Sc, Pharm.D, Ph.D, MBBS or MD
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 25th August, 2019
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