Analyst- Pharmacovigilance Associate
About the Role
Company Overview
ICON is an international organization that provides clinical research services and global healthcare intelligence with the aim of speeding up the process of developing novel drugs and treatment methods. With a presence across the globe, ICON works together with pharmaceutical companies, biotech organizations, and medical device organizations to ensure better results for patients.
The company operates on its values such as integrity, collaboration, agility, and inclusion. These values ensure the creation of a friendly work environment.
Job Summary
ICON requires a Pharmacovigilance Associate who has practical experience in handling cases in clinical trials and post-market. The key responsibility of this role involves case management as far as drug safety is concerned and reporting of adverse events as well as adherence to global pharmacovigilance regulatory requirements.
The selected candidate should be able to conduct case processing, from data entry to coding, writing, and quality control of narratives.
Key Responsibilities
Gather, evaluate, and process adverse event reports as per regulatory time frames and guidelines. Manage safety inbox, ensure receipt acknowledgment, and do case triaging and booking into safety database systems.
Input case details correctly and create well-written and succinct narratives. Code adverse events, drug products, and patient medical history using MedDRA and WHO-DD. Use appropriate product labeling and quality control.
Assess the seriousness, predictability, and causality of the cases. Ensure completeness and correctness of the information before closing the cases for submission. Pose questions and follow-ups to address gaps in information.
Collaborate with multidisciplinary teams to resolve safety issues and investigations. Keep current on the latest pharmacovigilance requirements and international safety guidelines.
ICSRs that are literature-based will be processed and make sure that monitoring criteria have been met. Help out with the process of reconciliation and aggregate reporting like PSUR and DSUR.
Mentoring of newly hired people in the team and SOPs review. Knowledge about SDEA, KPI, and SLAs should be there.
Qualification and Skill Requirement
Education: Bachelor’s degree in Life Sciences
Experience: Minimum 2 years of pharmacovigilance experience with hands-on case processing
The candidates should have good experience in processing clinical trials and post-marketing cases.
The candidates must have knowledge of issues like seriousness and causality related to pharmacovigilance.
The candidates should be aware of safety databases, MedDRA and WHO-DD coding systems and regulatory issues.
Knowledge of reconciliation and aggregation will be an added advantage.
Good analytical skills, attention to detail and multi-tasking are very important qualities.
Good communication and interpersonal skills are also essential.
Salary and Benefits
ICON provides a competitive salary package that is consistent with industry norms and qualifications of the candidates. The salary range for this role is INR 5.3-6.6 LPA. Salaries may consist of performance bonuses and annual appraisal.
ICON employees have access to health and wellness programs that consist of medical insurance and wellbeing programs. There are retirement and pension programs that ensure employees' financial stability in the future.
Other benefits offered by ICON include life insurance, disability insurance, and employee assistance programs. ICON also provides learning and development programs, thus ensuring continual improvement of skills and career development of employees.
ICON strives to create a healthy balance between work and private life for its employees.
Role Importance and Career Growth
As the Pharmacovigilance Associate, one is supposed to take up an important responsibility in assuring that patients are always safe through accurate and efficient management and reporting of adverse events.
The job will allow candidates to have good exposure to the complete pharmacovigilance process, regulations, and global safety systems. Candidates will have an opportunity to move ahead in their career to jobs such as Senior Drug Safety Associate, PV Specialist, or Safety Scientist within ICON or the life sciences industry.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Analyst – Pharmacovigilance Associate/ ICON.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant pharmacovigilance experience, case processing expertise, and familiarity with global safety regulations. Early applications are recommended.
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.