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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.
- Positive 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.

📌 Patient Safety Associate I (India)
🏢 Parexel
📍 India