Patient Safety Associate I

Parexel; India; On-site; INR 480,000 - 720,000; Full time

Job summary

Parexel is seeking a detail-oriented Patient Safety Associate I to join on-site at Mohali. You will support pharmacovigilance and drug safety operations across trials, ensuring regulatory compliance and high-quality safety reporting.

Responsibilities include processing ICSRs, literature reviews, and safety submissions, while contributing to data quality, audits, and cross-functional collaboration in a fast-paced environment.

Qualifications

• Master's in Pharmacy, or a PharmD or BDS degree or Master's in Life Sciences.
• Eligible candidates are 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.

Responsibilities

• Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, medical coding using 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 the generation of safety metrics.
• Ensure the accuracy, completeness, and regulatory compliance of safety data and documentation.
• Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates.
• Support the 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.

Skills

Pharmacovigilance

ICH guidelines

Attention to detail

Analytical thinking

Time management

Team collaboration

Education

Master's in Pharmacy

PharmD

BDS or Life Sciences Masters

Tools

Microsoft Office

Safety databases

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.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research.

We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a detail-oriented Patient Safety Associate I to join our team in on-site capacity, based in Mohali. As a Patient Safety Associate, you will support pharmacovigilance and drug safety operations across clinical trials and post-marketing activities. This position plays a key role in processing safety data, ensuring regulatory compliance, and contributing to high-quality safety reporting in line with global regulations and standard operating procedures (SOPs). You'll collaborate with cross-functional teams, follow industry-standard processes, and help ensure that patient safety data is accurate, complete, and ready for regulators.

Responsibilities include processing Individual Case Safety Reports (ICSRs), supporting safety submissions to regulatory authorities, and maintaining the accuracy and completeness of safety data, with opportunities to deepen your expertise and strengthen the quality of safety reporting.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through safety data processing, signal detection, and regulatory reporting. With diverse teams and continuous learning opportunities, the Patient Safety Associate can explore career paths and expand skills across pharmacovigilance and clinical research.

Key Responsibilities

• Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, medical coding using the 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 the generation of safety metrics.
• Ensure the accuracy, completeness, and regulatory compliance of safety data and documentation.
• Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates.
• Support the 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.

You'll thrive in this role if you bring:

• Strengths in attention to detail, analytical thinking, and time management.
• A background in life sciences, pharmacy, or a related field.
• The ability to collaborate across teams and communicate clearly.
• A patient-focused mindset and a commitment to high-quality work.
• Comfort working with Microsoft Office and a willingness to learn safety databases and processes.

Required Qualifications

• Master's in Pharmacy, or a PharmD or BDS degree or Master's in a related field in Life Sciences.
• Eligible candidates are 2025 and 2026 graduates only.
• Basic knowledge of pharmacovigilance, International Council for Harmonisation (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.

Preferred Qualifications

• Proficiency in Microsoft Office.
• Familiarity with safety databases.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in you