Patient Safety Associate I
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What you'll do
- 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.
What they're looking for
- 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.
- Ability to work effectively in a team and manage multiple tasks in a deadline-driven environment.
Nice to have
- Proficiency in MS Office and familiarity with safety databases is advantageous.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.
Company
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