Patient Safety Associate II / Patient Safety Specialist

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 Patient Safety Associate II/Specialist to join our Patient Safety Operations team in a Temporary assignment (Contract role for 9 months) for on-site capacity. As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients. This position plays a key role in safety case processing, regulatory submissions, literature surveillance, and compliance with international regulations. You will collaborate with cross-functional teams, follow industry-standard processes, and contribute to safety operations from study initiation through closeout. Responsibilities include processing safety reports, executing regulatory submissions, conducting literature reviews, coordinating with affiliates, and supporting regulatory intelligence activities. You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through ensuring patient safety and regulatory compliance. With diverse teams and continuous learning opportunities, the Patient Safety Associate II/Specialist can explore career paths and expand skills across global pharmacovigilance and clinical research. Key Responsibilities Monitor, process, and assess incoming safety reports from various sources, performing data entry and quality validation to ensure accuracy and compliance with regulatory standards Execute safety case processing workflows including MedDRA coding, causality assessment, expectedness determination, and preparation of case documentation and narratives Execute ICSR and periodic report submissions to regulatory authorities, maintaining compliance with global reporting timelines and regulatory requirements Implement literature search strategies, screen publications for adverse drug reactions, identify potential safety signals, and maintain alignment with global pharmacovigilance regulations Support communication and coordination between global safety operations and local affiliates, assisting with local health authority interactions and country-specific pharmacovigilance requirements Conduct quality assurance activities, perform data reconciliation, and participate in metrics collection and reporting to support continuous improvement initiatives Manage regulatory applications and product lifecycle changes in safety databases, supporting global regulatory activities across multiple regions Research and disseminate regulatory intelligence to internal teams and clients, maintaining a centralized repository of regulatory updates and contributing to development of standard operating procedures Collaborate with cross-functional teams and clients, attending meetings and coordinating activities to ensure timely delivery of safety deliverables Develop and maintain knowledge of safety profiles, labeling, global regulations, and internal procedures while following documentation and archiving standards You'll thrive in this role if you bring: Strengths in analytical thinking, problem-solving, and attention to detail Experience working in pharmaceutical, healthcare, or a regulated environment The ability to collaborate across teams and communicate clearly with internal and external stakeholders A patient-focused mindset and commitment to quality and regulatory compliance Comfort working with pharmacovigilance systems, databases, and MS Office applications Strong organizational and time management capabilities with the ability to manage multiple priorities Required Qualifications Bachelor's degree in Pharmacy, Nursing, Life Sciences, Health Sciences, or other health-related field (e.g., Biomedical Sciences, Microbiology, Biochemistry, Biotechnology, Dentistry), or equivalent qualification/work experience 2+ years of experience in safety case management, regulatory reporting, or pharmaceutical/healthcare environments Knowledge of ICH-GCP guidelines, regional pharmacovigilance requirements, and clinical trial processes Proficiency with safety databases and data analysis tools Strong communication, organization, and problem-solving skills Preferred Qualifications Advanced degree or professional certification in pharmacovigilance or regulatory affairs Experience with EudraVigilance, eCopy, or other pharmacovigilance systems Familiarity with regulatory submission processes and portal/gateway systems Experience in a global or multi-regional pharmacovigilance environment 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 your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!