Patient Safety Associate II / Patient Safety Specialist
About the Role
Company Description
Parexel is a clinical research company that has more than 22,000 people working in different parts of the world. The company partners with drug makers and research sites to create and manage trials that always put patients at the center. The company has been around for than 40 years and it combines strong local knowledge with global regulatory and therapeutic skills. Parexel acts quickly encourages ideas and tries to help new treatments reach patients as soon, as possible.
Job Summary
This is a temporary role, a nine month contract, based on-site with the Patient Safety Operations team. As a Patient Safety Associate II or Specialist, you will support pharmacovigilance work that helps bring new treatments forward safely. Your work will cover safety case processing, regulatory submissions, and literature checks. Work closely with different teams and help keep safety operations running smoothly from start to finish.
Key Responsibilities
Review and process incoming safety reports, checking data for accuracy and compliance
Handle safety case work including coding, causality checks, and case documentation
Prepare and submit safety reports to regulatory authorities on time
Search medical literature to spot possible safety signals and adverse reactions
Coordinate with local affiliates and support country specific safety requirements
Carry out quality checks, reconcile data, and help track team metrics
Manage regulatory updates and product changes within safety databases
Track regulatory news and keep the team informed with a shared knowledge base
Work with cross functional teams and clients to meet deadlines
Keep updated on Safety profiles labeling rules and internal procedures. Safety profiles, labeling rules and internal procedures.
Educational Qualification
Bachelor's degree in Pharmacy, Nursing, Life Sciences, Health Sciences, or a related health field.
At least 2 years of experience in safety case work, regulatory reporting, or a healthcare setting.
Skills Required
Understanding of ICH GCP guidelines and regional pharmacovigilance rules.
Comfortable using safety databases and data analysis tools.
Strong communication and organization skills.
Good problem solving ability and close attention to detail.
Comfortable managing several tasks and priorities at once.
Advanced degree or certification in pharmacovigilance is a plus.
Experience with EudraVigilance or similar systems is a bonus.
Salary Structure
The average salary for a Patient Safety associate at Parexel in India ranges from ₹5.6 Lakhs and ₹6.7 Lakhs per year.
Career Development
This role gives you hands on exposure to global pharmacovigilance and regulatory work. Over time, you can build new skills and explore different paths across clinical research and safety operations.
How to Apply
Visit our job portal and search for Patient Safety Associate II / Patient Safety Specialist - Paraxel.
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Check your education skills and experience, before sending the application.
Click. Finish all the needed details to successfully send your application.
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.