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!
