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Keywords / Skills : Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, medical terminology, MS Word/Excel/PowerPoint

2 - 3 years
Posted: 2018-03-12

Nationality
India
Industry
Bio Technology & Life Sciences
Function
Pharmaceutical/ Biotechnology
Role
Other Roles
Other Pharma
Education
Any graduate BSc
MSc
Stream:
Bio-Chemistry
Bio-Technology
Biology
Biomedical
• Botany
Chemistry
Microbiology
Pharmacy
• Other
Bio-Chemistry
Bio-Technology
Biology
• Botany
Chemistry
Microbiology
Statistics
• Other
Bio-Chemistry
Bio-Technology
Biology
• Botany
Chemistry
Microbiology
Statistics
Posted On
12th Mar 2018
Job Description
  • 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


About Company

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.
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