Medical Safety Lead

Novartis

6+ years years

Preffered by Company

Hyderabad

Not Disclosed May 13, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Research & Development

Job Title

Medical Safety Lead

Job Details

Job ID: REQ-10005505
Date Posted: May 06, 2024
Location: India
Division: Development
Business Unit: Pharmaceuticals
Site: Hyderabad (Office)
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No

Summary

In close collaboration with the Global Program Safety Lead (GPSL), this role provides robust safety evaluation expertise and medical innovation to improve patients’ lives and impact overall Novartis results. As a member of the Medical Safety organization, this position prioritizes patient safety, ensures optimal safety for assigned compounds, and shares responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management.

Major Accountabilities

Monitor clinical safety of projects/products, including literature review, evaluation of individual cases, signal detection, and responses to safety-related questions.
Perform medical assessments and related activities for single cases, including follow-up information collection, evaluation of product quality defects with adverse events, and preparation of periodic medical assessments for ethics committees.
Identify safety signals based on the review of solicited or unsolicited single cases. Conduct signal detection, monitoring, and evaluation using proper tools.
Provide inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepare safety data for Health Authority review boards and legal queries.
Support GPSL and Senior Medical Safety Lead in submission activities by providing pharmacovigilance inputs and preparation of safety documents (e.g., summary of clinical safety, clinical overview).
Prepare medical input to aggregate clinical safety regulatory reports.
Collaborate on the preparation of Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates. Provide guidance on coding and causality/expectedness assessment of adverse event reports.
Provide expert evaluation on the clinical context of adverse event reports and their implications on Novartis products.
Collaborate with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other departments on clinical safety tasks.
Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures. Support licensing activities, regulatory authority inspections, and project/product recall activities.

Minimum Requirements

Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in a relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports.
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).
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 clinical safety assessments and regulatory reports involving safety information.
Experience with (safety or other) issue management.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and there's potential to do even more. At the intersection of medical science and digital innovation, we believe diverse, equitable, and inclusive environments inspire new ways of working. Our culture underpinned by integrity, curiosity, and flexibility helps us collaborate courageously to tackle the world's toughest medical challenges. Imagine what you could do here at Novartis!

Join our Novartis Network

If this role isn't 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.

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