Preparation of Periodic Safety Update Reports (PSURs) from grouped data for pharmaceutical products in accordance with client/international conventions
Preparing PSURs in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
Liaising with various stakeholders involved in PSUR preparation
Performing quality check of PSURs as per client requirements
Responsible for archiving the finalized PSURs and supporting documents as per client requirements
Maintaining excellent knowledge of the safety profile of the assigned products, client’s 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
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 processing of the reports
Identifying areas of concern within the team and raising the issues with the Project Manager
Providing support for audits and inspections; involved in inspection readiness activities, as required
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Job Description :
To ensure customer service and support all operations. To create customer delight at every interaction.
Interacting with external customers and internal customers and addressing their queries, requests and complaints.
Committed TATs are met consistently
Complaints Management- addressing customer complaints at the branch, system updation, coordination with Sales/HUB/ other functions for resolution.
Refunds processing and dispatch
Undelivered policy documents tracking and management.
Maintenance of all files and registers.
New Business Processing:-
Handling end to end New business processing starting from creation of Client id,Case start up, New business login, Follow up for policy issuance, Quality Check
Follow up with HUB for policy issuance of pending cases