Job Description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Summary:
We are seeking a detail-oriented Patient Safety Associate to support pharmacovigilance and drug safety operations across clinical trials and post-marketing activities. The role involves processing safety data, ensuring regulatory compliance, and contributing to high-quality safety reporting in accordance with global regulations and standard operating procedures (SOPs).
Key Responsibilities:
- Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, coding (Medical Dictionary for Regulatory Activities [MedDRA]), narrative writing, and quality checks.
- Perform literature searches and reviews to identify potential adverse drug reactions and safety signals.
- Support safety submissions to regulatory authorities, ethics committees, and other stakeholders within required timelines.
- Assist in signal detection, compliance tracking, and generation of safety metrics.
- Ensure accuracy, completeness, and regulatory compliance of safety data and documentation.
- Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates.
- Support preparation of aggregate reports and maintain safety reporting schedules.
- Contribute to regulatory intelligence activities by tracking safety reporting requirements and updates.
- Participate in audits, inspections, and quality improvement initiatives as required.
- Collaborate with cross-functional teams and support client communication under supervision.
Qualifications & Skills:
- Master’s Degree in Life Sciences, Pharmacy, or related field or PharmD or BDS degrees. Eligible candidates: 2025 and 2026 graduates only.
- Basic knowledge of pharmacovigilance, ICH guidelines, and global safety reporting requirements.
- Strong attention to detail and analytical skills.
- Good communication, organization, and time management abilities.
- Proficiency in MS Office and familiarity with safety databases is advantageous.
- Ability to work effectively in a team and manage multiple tasks in a deadline-driven environment.
Preferred Experience:
Prior experience or internship in pharmacovigilance, clinical research, or healthcare setting is preferred.