Medical Safety Lead

NOVARTIS

8 - 13 years

11 - 15 Lacs

hyderabad

Posted:15 hours ago| Platform:

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Skills Required

medical affairs data management coding pharma clinical trials clinical development pharmacovigilance medical records licensing monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Monitors the clinical safety of projects/productsincluding 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 adverse event reports
Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products
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
Provides safety inputs for clinical and regulatory deliverables including clinical study protocols, clinical study reports, and investigator brochure
Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed
Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities

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