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
โ Case Processing & Safety Reporting
- Processย Individual Case Safety Reports (ICSRs)ย from various sources.
- Conductย literature searches, signal detection, and regulatory tracking.
- Performย regulatory submissionsย and support aggregate report preparation.
โ Compliance & Quality Control
- Ensure ICSR compliance withย global and local regulatory requirements.
- Conductย quality reviews, generate metrics, and investigate late cases.
โ Database & Documentation Management
- Assist inย safety database setup, data entry guidelines, andย user acceptance testing (UAT).
- Performย electronic documentation, case narratives, and query management.
โ Regulatory & Medical Support
- Assist inย expedited reporting proceduresย and submissions to regulatory authorities.
- Supportย Medical Directors/Safety Physiciansย in medical monitoring activities.
โ Audits & Training
- Participate inย internal/external auditsย and inspections.
- Attendย drug safety trainingย and client meetings as required.
Skills & Qualifications
Required Experience
- 2+ yearsย inย pharmacovigilance/drug safety.
- Experience inย ICSR processing, literature reviews, and regulatory submissions.
Educational Background
- Degree in Pharmacy, Nursing, Life Sciences, or related field.
- Medical/Dentistry/Physiotherapy/Nursingย degree with patient exposure is a plus.
Key Skills
โ Strong analytical & problem-solving abilities
โ Excellent communication & organizational skills
โ Proficiency in safety databases & literature searches
โ Ability to work in a team-oriented, client-focused environment
Why Join Parexel?
๐ Global Impact: Contribute to life-saving therapies.
๐ Career Growth: Opportunities for professional development.
๐ค Collaborative Culture: Work with industry experts in a supportive environment.