Novartis Hiring Medical Safety Lead Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD)
Job Description
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.
• 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 safety inputs for clinical and regulatory
deliverables including clinical study protocols, clinical study reports, and
investigator brochure.
• 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.
• 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.
Minimum requirements
• 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 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 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
• Experience in preparing or contributing to preparation of
clinical safety. Assessments and regulatory reports involving safety
information
• Experience with (safety or others) issue management.
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