Novartis
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.
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