GDPS (Global Drug Product Safety)
About the Role
Company Overview
Elanco is one of the world’s leading organizations in the field of animal health. This organization aims to provide innovative solutions to protect farm animals from various diseases. The vision of the organization is companionship enriching life, and its main aim is to improve animal health, which will have an effect on people, communities, and the environment.
Elanco offers diversity and inclusiveness, which will help employees innovate and collaborate to make advancements in the field of animal healthcare.
Job Summary
The recruitment for the position of an Analyst – GDPS is currently underway at Elanco Pharmaceuticals. The analyst will be working under the pharmacovigilance function based out of Bengaluru. The main job responsibility of this profile is handling adverse event case processing.
The job entails the assessment of cases for issues related to seriousness and causality, along with ensuring compliance with all global pharmacovigilance standards and deadlines.
Key Responsibilities
Conduct case management of adverse events, including data entry in pharmacovigilance databases. Evaluate the cases for seriousness, causality, and reportability. Make sure all the safety cases are accurately completed and in compliance with regulations.
Verify the entered data against the source documents and call notes. Conduct self-audits on the cases for quality and completeness of the case. Find out any missing information and the need for follow-up.
Make sure all the cases are submitted in time and in compliance with the internal and global pharmacovigilance guidelines. Find out any delays or issues in the process and report them.
Maintain productivity and quality metrics for multiple cases. Attend team meetings regularly and work with the internal stakeholders. Carry out any other duties as assigned.
Technical and Functional Skills
Have sound knowledge of the terminology used in the field of pharmacovigilance and for reporting adverse events. Have an understanding of basic concepts in pharmacovigilance and regulations involved.
Have excellent communication skills in both writing and speaking. Be able to communicate effectively with internal and external groups.
Have the ability to handle multiple products and be able to prioritize assignments effectively. Have good interpersonal relationships within cross-functional teams.
Be able to deal with multiple databases and systems. Be flexible to handle heavy workload and long hours as necessary.
Qualification and Skill Requirement
Education: Veterinary degree equivalent to DVM from the United States of America with or without experience in pharmacovigilance
OR
M.Pharm degree in Pharmacy with experience in pharmacovigilance.
Experience: 0 to 2 years of experience in the relevant field of pharmacovigilance is preferable.
Candidates need to have comprehensive knowledge regarding the reporting process of adverse events. Knowledge of pharmacovigilance databases and global regulatory requirements is an extra benefit.
Attention to detail and analytical skills are crucial. The candidate needs to have strong communication skills along with time management skills.
Additional Information
There is no travel requirement. The work location is Bengaluru, India. This is a full-time employment opportunity.
Role Importance and Career Growth
This job is essential in safeguarding the safety of animal health products by reporting adverse events accurately. The analyst directly participates in pharmacovigilance activities on a global level.
The job is a great start for those who want to be involved in pharmacovigilance, since it will help them get acquainted with safety systems, regulations, and processing workflow. With experience, one can move up the career ladder to become Senior Drug Safety Associate, PV Specialist, or Safety Scientist.
How To Apply
If you're interested in this role, you can apply by:
Create your account on Jobslly.
Search for the job Analyst – GDPS (Global Drug Product Safety)/ Elanco.
Upload the updated resume.
Upload all relevant certifications.
Fill out the application form.
Make sure to have relevant qualifications and knowledge of pharmacovigilance in your resume. Also, specify the experience you have with data handling and reporting of adverse events.
It is advisable to apply earlier, as the openings may close as soon as a suitable candidate is selected.
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.