Patient Safety Associate I (Drug 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.
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 Patient Safety Associate I (Pharmacovigilance Associate, Drug Safety Associate) to join our team. This role supports critical patient safety and pharmacovigilance activities that help ensure the safe and compliant development of therapies for patients worldwide.

As a Patient Safety Associate I, you will contribute to a broad range of safety operations, including individual case safety report processing, safety submissions, literature review activities, affiliate support, regulatory support, and regulatory intelligence activities. Working within established procedures and under appropriate supervision, you will play an important role in maintaining compliance with global regulatory requirements and supporting the delivery of high quality patient safety services.

You will gain exposure to a wide range of pharmacovigilance processes while collaborating with experienced professionals across global teams. This role offers an excellent opportunity to build expertise in drug safety, regulatory compliance, and clinical research while contributing to activities that help protect patients and support the development of innovative therapies.
Key Responsibilities

- Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data.

- Perform data entry, case creation, case processing, quality checks, coding activities, follow up activities, and case narrative preparation within safety databases in accordance with client requirements and standard operating procedures.

- Support compliance with regulatory reporting requirements through accurate processing, documentation, reconciliation, and tracking of safety cases and submissions.

- Conduct literature searches, screen and review scientific literature, identify potential safety information, and support literature monitoring activities.

- Manage submission of Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and other stakeholders.

- Support affiliate services activities, including safety information exchange, literature screening coordination, translation support, follow up activities, and data reconciliation.

- Maintain documentation, records, and project files in applicable systems, including EDMS and eTMF environments.

- Support regulatory operations by maintaining regulatory databases, tracking submissions, supporting registrations, and assisting with lifecycle management activities.

- Participate in regulatory intelligence activities by researching, maintaining, and updating country specific safety reporting requirements and associated record