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Indegene Hiring For PSUR Writing Role - Bangalore - Immediate Joiners

3.00 to 6.00 Years   Bangalore   09 Oct, 2021
Indegene Private Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaHospital Management / Director,Medical Transcription
EmploymentTypeFull-time

Job Description

Greetings from Indegene !We are hiring for PSUR Writing role.Interested candidates may send in their updated resume for the rounds of discussion.HR - Nivedita -nivedita.patra@indegene.comPls find below the JD :Experience : 3-5 yearsImmediate joiners onlyLocation :Bangalore

  • Good communication and analytical skills.
  • Knowledge of EU MDR 2017/745, Rev 4.0 guidelines
  • Knowledge of overall PMS process for the Medical Devices
  • Responsible for end-to-end creation of the PSUR
  • Good understanding of Clinical trials, Adverse events, Serious Adverse Events, Adverse Device effects and Medical Device documents including CER, PSUR, PMS plan, IFU, PMCF plan/report, Risk Files and sales data tables.
  • Basic understanding of definitions of therapeutic areas like Cardiovascular, Neurology, Respiratory, Renal, Gastroenterology etc.
  • Literature articles analysis summarization of safety and performance field, extraction of AE data and identify device specific risks.
  • Complaint data analysis to calculate occurrence rate of AEs.
  • Knowledge to perform vigilance database search.
  • Quality check (QC), Quality Assurance (QA), and Peer Review (PR) of deliverables.
  • Attaching relevant emails and source documents in the share-folders.
  • Well-versed with MS Office.
  • Previous experience in PSURs, PBRERs, SUSARs is preferable.

Keyskills :
mdrmedical devicespsur writingclinical trialstherapeutic areaspmsdata analysisquality checksusarspbrer

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