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PSUR Coordinator

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Coordination of safety reports preparation and 100% Quality Control of PSUR projects assigned to PLSS, review assigned PSUR and related safety reports for Novartis Pharma marketed product portfolio. Write safety reports, and support preparation of Standard Operating Procedures (SOP), templates and business guidance writing. Maintain compliance of safety reports preparation within PLSS by timely delivering high quality documents according to the defined timelinesMajor Accountabilities Maintain assignments for Periodic Safety Update Reports (PSURs), PSUR Addendum Reports (ARs), Bridging Documents (BDs) and US Periodic Reports (USPRs) within PLSS Hyderabad. 2. Authoring of Periodic Safety Update Reports (PSURs), PSUR Addendum Reports (ARs), Bridg- ing Documents (BDs) and US Periodic Reports (USPRs). 3. Perform quality control (QC) of PSURs as per SOPs/guidelines and provide feedback to au- thors to ensure quality standards are maintained across the organization. 4. Correction of PSUR comments and individual case reports, as needed. 5. Advise Hyderabad PLSS associates on regulatory requirements and other safety reports re- lated questions. 6. Ensure full compliance of all periodic reports written in SP&R Hyderabad with DS&E SOP timelines and in case of a delay investigate root cause and implement corrective action. Be aware of the global compliance reporting rate. 7. Support writing of PSUR/AR/BD templates and SOPs and update as necessary according to emerging regulatory requirements. 8. Be aware of the global compliance reporting rate. 9. Provide training to authors within Hyderabad organization. 10. Participate in cross-functional teams as needed. 11. Provide support as required for regulatory authority inspections and audits.Minimum requirements Degree in life sciences or equivalent. English Previous experience in handling medical safety data. Minimum 3 years of experience in the pharmaceutical industry, particularly drug safety. Familiarity with medical terminology and working with large databases. Maturity to deal and interact with a wide variety of people at all levels. Previous administrative or office experience. Experience of working with and supporting a team advantageous. Knowledge/Proficiency of MS Office (Word, Excel, Power- Point) and Lotus Notes.Successful and timely delivery of high quality PSUR and related safety reports to Drug Regulatory Affairs for submission to Health Authorities. 2. Quality of deliverables according to established directives. Compliance with internal and external regulations and procedures.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 3-8


Basic Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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