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.
