Patient Safety Associate I (Drug Safety Associate I)

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Patient Safety Associate I (Drug Safety Associate I)
Primary Location: United States, Remote Job ID R0000045637 Category Medical Affairs
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About This Role
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 records.
Participate in project meetings, training programs, audits, inspections, and other assigned departmental activities while escalating issues to supervisors as appropriate.
Candidate Profile
You'll Thrive In This Role If You Bring
Strengths in organization, attention to detail, and analytical thinking.
An interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare environments.
The ability to collaborate effectively with team members and communicate clearly.
A patient focused mindset and commitment to quality and compliance.
Experience working with pharmacovigilance systems, databases, Microsoft Office applications, and established workflows.
A strong desire to learn, develop new skills, and contribute to clinical research and patient safety initiatives.
Required Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience.
Foundational knowledge of drug safety regulations and pharmacovigilance processes. Ideal candidate has 3+ years experience in Drug Safety.
2+ years experience in post marketing.
Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease).
Strong attention to detail, organizational skills, and problem solving ability.
Effective communication and willingness to work in a collaborative team environment.
Proficiency with MS Office and ability to learn safety systems/databases. Preference for those with Veeva Safety experience.
Benefits And Compensation
Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
For a complete list of benefits, please visit www.parexel.com/us-benefits (opens in new window).
We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
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.
This role offers the flexibility to work from home in the US.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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