Preparing end to end PSURs (including ad-hoc requests) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
• Liaising with the relevant stakeholders regarding discrepancies, and for obtaining incomplete/missing information (where required), in order to resolve and clarify issues and to facilitate the processing of the reports
• Maintaining excellent knowledge of the safety profile of the assigned products, clients procedures, and international drug safety regulations
• Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client
• Performing self QC of reports
• Ensuring MedRDA coding in accordance with MedRDA Term Selection: Points to consider where applicable
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices nearly 80 locations in over 50 countries around the world, and has approximately 18,000 employees.
In India, PAREXEL has seven offices spread across five cities: Bengaluru, Hyderabad, Chandigarh, New Delhi and Mumbai. These offices are home to more than 3,000 employees.
Our two new offices in Bengaluru, called IndiQube and EcoWorld, were strategically designed to support a variety of work styles. There are collaboration zones in bright colors, freestanding high tables with stools to serve as informal meeting spaces, quiet rooms for group meetings, and private booths for phone calls. This innovative workspace encourages teamwork, and allows for sufficient flexibility to utilize the office beyond workstations.