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

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Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, coding (Medical Dictionary for Regulatory Activities [MedDRA]), narrative writing, and quality checks.

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Perform literature searches and reviews to identify potential adverse drug reactions and safety signals.

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Support safety submissions to regulatory authorities, ethics committees, and other stakeholders within required timelines.

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Assist in signal detection, compliance tracking, and generation of safety metrics.

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Ensure accuracy, completeness, and regulatory compliance of safety data and documentation.

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Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates.

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Support preparation of aggregate reports and maintain safety reporting schedules.

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Contribute to regulatory intelligence activities by tracking safety reporting requirements and updates.

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Participate in audits, inspections, and quality improvement initiatives as required.

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Collaborate with cross-functional teams and support client communication under supervision.

Qualifications & Skills

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• Master’s Degree in Life Sciences, Pharmacy, or related field or PharmD or BDS degrees. Eligible candidates: 2025 and 2026 graduates only.
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• Basic knowledge of pharmacovigilance, ICH guidelines, and global safety reporting requirements.
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• Strong attention to detail and analytical skills.
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• Good communication, organization, and time management abilities.
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• Proficiency in MS Office and familiarity with safety databases is advantageous.
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• Ability to work effectively in a team and manage multiple tasks in a deadline-driven environment.