Parexel is a leading global clinical research organization (CRO) committed to improving world health through innovative clinical trials, regulatory consulting, and market access solutions. With a strong focus on patient safety and drug development, Parexel ensures that every clinical solution is backed by expertise and empathy.

At Parexel, every employee plays a crucial role in bringing life-changing therapies to patients worldwide. If you are passionate about pharmacovigilance and drug safety, this is your opportunity to make a difference!

Job Description: Drug Safety Associate II

Job Purpose

The Drug Safety Associate II will provide technical and process-related support for drug safety management (clinical trial and post-marketed) and medical monitoring activities. The role ensures compliance with regulatory requirements and standard operating procedures (SOPs).

Key Responsibilities

✅ Case Processing & Safety Reporting

• Process Individual Case Safety Reports (ICSRs) from various sources.
• Conduct literature searches, signal detection, and regulatory tracking.
• Perform regulatory submissions and support aggregate report preparation.

✅ Compliance & Quality Control

• Ensure ICSR compliance with global and local regulatory requirements.
• Conduct quality reviews, generate metrics, and investigate late cases.

✅ Database & Documentation Management

• Assist in safety database setup, data entry guidelines, and user acceptance testing (UAT).
• Perform electronic documentation, case narratives, and query management.

✅ Regulatory & Medical Support

• Assist in expedited reporting procedures and submissions to regulatory authorities.
• Support Medical Directors/Safety Physicians in medical monitoring activities.

✅ Audits & Training

• Participate in internal/external audits and inspections.
• Attend drug safety training and client meetings as required.

Skills & Qualifications

Required Experience

• 2+ years in pharmacovigilance/drug safety.
• Experience in ICSR processing, literature reviews, and regulatory submissions.

Educational Background

• Degree in Pharmacy, Nursing, Life Sciences, or related field.
• Medical/Dentistry/Physiotherapy/Nursing degree with patient exposure is a plus.

Key Skills

✔ Strong analytical & problem-solving abilities
✔ Excellent communication & organizational skills
✔ Proficiency in safety databases & literature searches
✔ Ability to work in a team-oriented, client-focused environment

Why Join Parexel?

🌍 Global Impact: Contribute to life-saving therapies.
📈 Career Growth: Opportunities for professional development.
🤝 Collaborative Culture: Work with industry experts in a supportive environment.

How to Apply

Application Link