Medical Review Physician (ICSR)
About the Role
Company Overview
ClinChoice is a well-known global full-service CRO organization that specializes in the provision of quality clinical development, pharmacovigilance and regulatory services. With a significant presence in various geographic areas, ClinChoice ensures delivery of efficient and innovative solutions to facilitate drug development and promote patients' safety.
At ClinChoice, professionals strive for excellence in everything they do. The teams within ClinChoice are involved in global projects which give them an opportunity to learn about the international standards in clinical research and pharmacovigilance.
Job Summary
ClinChoice is looking for an experienced Medical Review Physician specializing in ICSR (Individual Case Safety Report) Medical Review to be a part of their dynamic pharmacovigilance team.
The ideal candidate should hold an MBBS/MD degree with a minimum of 2–4 years’ worth of practical experience in medical review domain, motivated to ensure drug safety and compliance. As a reviewer for safety data, you would be responsible for ensuring accuracy and validity of the information in your report.
This role will be based in Bengaluru, India and offers a hybrid work schedule.
Key Responsibilities
The Medical Review Physician is tasked with undertaking a thorough medical review of Individual Case Safety Reports (ICSRs). They ensure that they are accurate, complete, and clinically relevant. The individual will also undertake causality assessment as well as assessment of seriousness and expectedness of adverse events based on regulatory guidance from bodies like ICH-GCP, GVP, and 21 CFR. The physician will also be required to perform reviews and editing of case narratives, as well as contribute to the identification of safety signals as well as signal detection process. Collaboration between the individual and other departments like case processing and quality assurance will be essential to ensure that pharmacovigilance procedures are maintained at the highest level. Besides, medical information for aggregate reports like PSURs and DSURs will be provided by the physician.
Qualifications and Skills
Educational Qualification and Experience:
MBBS or MD with 2–4 years of experience in ICSR Medical Review.
Key Skills & Competencies:
The ideal candidate should have good understanding of pharmacovigilance process and workflow and good understanding of regulatory guidelines such as ICH-GCP, GVP Modules, 21 CFR. They must exhibit good clinical judgment and analysis skills along with great attention to detail and ability to understand complicated medical data. Excellent written and verbal communication skills are mandatory along with the ability to work alone and also as part of a team. Good experience with safety databases like Argus, ArisG, or similar will be an added advantage. In addition, good time management skills and organization skills are required.
Salary and Benefits
ClinChoice offers you a competitive market salary based on industry norms and experience level. Salary offered for this position is INR 14-15 LPA. Negotiations are welcome.
Furthermore, the firm offers a hybrid schedule of work. There will be various opportunities for you to handle pharmacovigilance projects in multiple international locations. You will be given learning and development programs that will help you gain experience in international regulations.
The firm has a collaborative and an inclusive working environment along with a stable career opportunity.
Importance of the Role
The importance of a Medical Review Physician cannot be overstated when it comes to patient safety and data integrity. Your knowledge in the field of review of ICSRs plays a very important part in the identification of risks related to drug products.
Your contribution to the assessment and reporting of adverse events plays an essential part in ensuring the safety of people’s lives and ensuring compliance. This job is more than just reviewing. It helps to ensure the safety of drugs all around the world.
Career Growth Opportunities
ClinChoice strongly feels that their employees require empowerment to move ahead in their careers. If you become a Medical Review Physician at ClinChoice, then you will have the chance to:
Be exposed to career advancement prospects in terms of positions of seniority in medical review or pharmacovigilance management
Interact with international clients in various therapeutic areas
Gain more insight into the drug safety and regulation through training programs
Work in various fields like medical affairs, signal detection, and risk management
Work on various projects for the company
Your career with us will be one of growth and learning.
How To Apply
If you are a motivated medical professional with a passion for pharmacovigilance and drug safety, we encourage you to apply.
Create your account on Jobslly.
Search for job Medical Review Physician (ICSR) – Pharmacovigilance / Clinchoice
Upload updated resume.
Highlight experience in ICSR medical review and regulatory knowledge.
Upload any relevant certifications in Clinical Research.
Submit the completed application.
Join the leading CRO and help people lead a safer life.
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.