Senior Medical Safety Lead – Immunology

  Medical Writing

Job title: Senior Medical Safety Lead – Immunology

Company: The Medicines Company

Job description: 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 k

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 medicines. 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. [#video#https://www.youtube-nocookie.com/embed/ggbnzRY9z8w#400,300##/video#] 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. 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.

Expected salary:

Location: Hyderabad, Telangana – Secunderabad, Telangana

Job date: Sat, 11 Jun 2022 22:41:49 GMT

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