Patient Safety Associate I

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.

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.