Subject Matter Expert (SME), Medical Safety
Subject Matter Expert (SME), Medical Safety
Cognizant
Job description
Cognizant are looking to hire a Subject Matter Expert, Medical Safety in Hyderabad, Mumbai and Bangalore. You will work in a hybrid environment as part of a team at Cognizant.
Company Description
Cognizant is a company that builds AI and provides technology services. They create AI solutions that help businesses get the most out of AI. With industry, process and engineering knowledge they embed a company’s unique context into technology systems to unlock human potential and deliver real results keeping global enterprises ahead.
Job Summary
This role gives you the chance to work as a Subject Matter Expert: Medical Safety. You will use your research and development skills to create effective products in a global pharmaceutical setting. You will help with risk assessment interpreting safety data and other medical safety tasks in a workplace.
Key Responsibilities
The key responsibilities of SME: Medical safety roles are:
Use your medical safety knowledge to interpret non‑clinical data collected during research and development in the pharmaceutical sector.
Carry out medical safety assessments on aggregated case data from clinical trials and post‑marketing.
Evaluate severity, causality and patient safety impact.
Work with R&D teams to give medical safety input for study protocols informed consent documents and safety monitoring plans.
Review and enhance safety sections in key documents such as risk management narratives and summary reports. Make sure medical interpretations match company safety standards.
Help with signal detection. Analyse safety trends to create summaries and recommend ways to improve product safety.
Work with Pharmacovigilance and Clinical Operations to clarify case details. Resolve discrepancies to improve accuracy.
Assist in preparing responses to safety queries from regulators and internal stakeholders. Ensure responses are Data‑driven.
Make sure accurate documentation is completed in the right tools. Record rationale, decision making and summarise review outcomes.
Attend meetings during the day shift, discuss safety issues and share insights from safety reviews.
Help develop and improve internal Medical Safety processes. Share knowledge gained from case work.
Help the company deliver effective therapies to people and communities. Use judgement to analyse safety data and spot potential risks.
Keep learning and improving knowledge of Medical Safety research and development.
Educational Qualification
Educational qualifications required for SME: Medical safety role are:
Proven experience in research and development.
2 to 3 Years of experience in safety aspects of clinical studies or product development.
Skills required
Skills required for SME: Medical Safety role are:
Desirable to have a certified qualification in Pharmacovigilance or Drug Safety for example the Pharmacovigilance Professional Certification.
Know how to assess events, severity and causality.
Understand Pharmacovigilance processes and medical review including PV medical review.
Strong analytical and critical thinking skills will help you interpret complex medical data identify key safety insights and explain them clearly to non‑medical colleagues.
Excellent written and verbal communication skills will let you produce concise safety summaries, medical narratives and responses.
Experience with common safety and clinical data systems such as Electronic Data Capture systems or safety databases.
Committed to practicing medicine and ensuring patient safety.
Salary Structure
The average salary for a Subject Matter Expert: Medical Safety at Cognizant in India is ₹6.7 Lakhs to ₹7.03 Lakhs, per year.
Career Development
As a Medical Safety subject matter expert, you will have access to a range of learning opportunities. These opportunities include Pharmacovigilance certifications, Medical Compliance training and leadership development. The structured career paths will give Medical Safety subject matter expert the chance to move into advisory roles people management or global safety roles. Medical Safety subject matter expert will work together with healthcare teams and will be exposed to new safety technologies. This experience will keep your knowledge growing and will give you impactful knowledge in the industry.
How to Apply
Go to our jobs page and search for the Subject Matter Expert (SME), Medical Safety at Cognizant.
Click on the role to see further details.
Complete your details and upload your CV.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Start from our Drug Safety resume template, with example points and skills ready to click in. ATS-friendly, and downloads as a PDF.
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.