Case Specialist, Clinical Trial Cases
Case Specialist, Clinical Trial Cases
ProductLife Group
Job description
Looking to build a career in pharmacovigilance and clinical trial safety review? Explore this Case Specialist, Clinical Trial Cases role at ProductLife Group.
Company Description
ProductLife Group is a company that works in the life sciences field. It was started in 1993. Has its main office in France. The company provides services related to rules and regulations quality control and tracking side effects of medicines. These services are offered to companies that make medicines medicines made from living things and devices used in healthcare. The company is active in, than 150 countries. ProductLife Group helps products from the time they are created until they are no longer used. The company keeps its attention on making sure patients can get useful healthcare treatments.
Job Summary
This remote role is based in India, supporting pharmacovigilance activities for clinical trial safety cases. As a Case Specialist, you will handle the quality control and medical evaluation of vigilance reports. Your work will include coding cases, assessing causality, and identifying reporting requirements. The role also involves validating documents, closing safety files, and supporting broader medical information needs across specific client accounts.
Key Responsibilities
Perform quality control checks on vigilance cases.
Carry out medical evaluation of safety reports.
Enter vigilance case data into required databases or formats.
Follow up on vigilance cases through phone calls or emails.
Conduct pre analysis of complex cases before data entry.
Code cases correctly, following the applicable coding dictionary.
Assess causal relationships between suspect products and reported effects.
Identify whether events are expected, listed, or unlisted.
Evaluate the seriousness of each event and case overall.
Identify submission requirements for each individual case.
Validate documents prepared by data managers or vigilance associates.
Close vigilance files once all required steps are complete.
Support updates to ICSR or MLM filters, as needed.
Review inclusion or exclusion criteria for EV or MHRA cases.
Support the medical information team with related queries.
Take part in other client specific activities as required.
Educational Qualification
A medical or pharmacy degree is required.
Skills Required
At least 4 years of experience in quality control for pharmacovigilance cases.
At least 3 years of experience processing clinical trial cases.
Experience using SafetyEasy or Argus databases.
Strong knowledge of current pharmacovigilance regulations.
Process oriented mindset, with strong attention to detail.
Ability to work well independently and within a team.
Good working knowledge of Microsoft Office tools.
Ability to manage multiple tasks with flexibility.
Excellent communication skills in both English and French.
Salary Structure
The salary for a Case Specialist (Clinical Trial Cases) at ProductLife Group in India typically ranges from ₹8 Lakhs and ₹15 Lakhs per year.
Career Development
This role offers hands on exposure to global pharmacovigilance work within a well established life sciences consulting company. ProductLife Group also supports long term growth through international project exposure and opportunities to build deeper expertise in clinical safety review.
How to Apply
Visit our job portal and search for the Case Specialist, Clinical Trial Cases role - ProductLife Group.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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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.