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PAREXEL International LLC
Company Name
Parexel International India Private Limited
Chandigarh, Mohali
2 - 3 years
Key Skills
Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, medical terminology, MS Word/Excel/PowerPoint
• Other Roles • Other Pharma
Bio Technology & Life Sciences
Posted On
12th Mar 2018
  PAREXEL International Corporation is a leading global bio/pharmaceutical services organization providing a broad range of knowledge-based contract research  
  Drug Safety Associate  
  Company profile | All Jobs by this Recruiter  

  • 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





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