Are you passionate about making a difference in healthcare? At Parexel, we share a common goal – improving health worldwide. Whether it’s through clinical trials, regulatory consulting, or market access, every solution we provide is driven by a deep belief in our work.
- Job Title: Drug Safety Associate-II
- Location: Mohali, India
- Time Type: Full Time
- Job Requisition ID: R0000023755
Why Work at Parexel?
- Shared Goals: We’re all working towards better health for everyone.
- Personal Impact: Every job here helps create therapies that benefit patients.
- Empathy and Commitment: We care deeply about our work and the people it helps.
About Parexel
Parexel is a leading global clinical research organization. We are headquartered near Boston, Massachusetts, and in Durham, North Carolina. We have over 16,000 employees and support clients in more than 100 countries. Parexel provides the most comprehensive drug development capabilities of any CRO (Contract Research Organization) worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
Job Description: Drug Safety Associate-II
As a Drug Safety Associate-II at Parexel, you will play a crucial role in ensuring the safety of new drugs. This is a great opportunity for someone with a passion for healthcare and drug safety.
Key Responsibilities:
Drug Safety Support:
- Help create safety procedures, workflows, and templates for projects.
- Assist in setting up safety databases and data entry guidelines.
- Review incoming reports to ensure they are complete, clear, and valid.
- Document and quality check drug safety information electronically.
- Enter case reports into the safety database or tracking system.
- Request follow-up information and manage queries.
- Code data in the safety database and write case narratives.
- Keep project files and case reports organized and up to date.
- Support Drug Safety Specialists and Project Leaders as needed.
- Inform managers of any potential changes in project scope.
- Assist Medical Directors and Safety Physicians in medical monitoring.
- Participate in client and investigator meetings.
- Attend training sessions specific to drug safety and projects.
- Perform literature searches and prepare for audits and inspections.
- Delegate tasks to Drug Safety Assistants when appropriate.
- Help develop expedited reporting procedures.
- Assist with electronic reporting registrations on behalf of sponsors.
- Support global reporting requirements to regulatory authorities and other stakeholders.
- Submit safety reports to investigators using the International Safety Information System (ISIS).
- Measure and track site performance in completing required tasks in ISIS.
- Assist with unblinding of SUSARs (Suspected Unexpected Serious Adverse Reactions) as needed.
- Collect and review metrics to ensure reporting compliance.
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Skills Needed:
- Strong analytical and problem-solving skills.
- Ability to perform database and literature searches.
- Excellent interpersonal, verbal, and written communication skills.
- Great organizational and prioritization abilities.
- Team player who can work collaboratively and effectively.
- Client-focused approach to work.
- Proficient with computer applications.
Experience and Education:
- Experience: Minimum 2 years in ICSR (Individual Case Safety Report) case processing.
- Education: Degree in Pharmacy, Nursing, Life Sciences, or a related health field, or an equivalent qualification.
Helpful Links:
How Pharmacovigilance Interviews Are Conducted?
Pharmacovigilance Interview Questions PDF 2024
Join Us and Make a Difference!
At Parexel, your work as a Drug Safety Associate-II will have a real impact on patients’ lives. We offer a supportive environment where your skills and dedication can shine. If you’re ready to be part of a team that is dedicated to improving global health, apply today!
Apply Now and take the first step towards a fulfilling career as a Drug Safety Associate-II at Parexel!