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Regulatory Reporting

0.00 to 5.00 Years   Kochi   04 Feb, 2021
GETTJOBS Recruitment Firm Hiring For Client
Job LocationKochi
EducationNot Mentioned
SalaryRs 2.5 - 4.0 Lakh/Yr
IndustryPharma / Biotech
Functional AreaAllied Health Services
EmploymentTypeFull-time

Job Description

Immediate hiring for regulatory reporting profile with salary up to 3.96lpatemporary work from homeJob title: operations specialist -1Experience: min 6 months of regulatory reporting + case processingEducation: any medical backgroundLocation: bangalore, thane, kochiLegacy quintiles/ ims: legacy quintilesNotice period: immediate joiner preferredKnowledge & experience required:-

  • Experience in post marketed icsr regulatory reporting or any kind or regulatory submissions
  • Experience in determining and assessing icsr report ability to various regulatory authorities based on appropriate regulatory intelligence.
  • Knowledge about concepts of post-market reporting ich e2d should be beneficial on cross reports across licenses of a pharmaceutical product.
  • Should have experience and knowledge of various formats of icsr reporting that is submitted to regulatory authorities, like xml format for evweb upload, e2b gateway reporting and transmission, portal submissions, courier and manual email submissions of cioms, medwatch.
  • Experience in icsr regulatory submission and regulatory guidelines for vaccines for various countries.
  • Knowledge of fda guidance on vaccines, vaers system, and ema vaccine guideline, gvp vi will also be helpful.
  • Knowledge of automated and manual scheduling of regulatory reports in the safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report.
Contract period: 6 months to 9 monthsPlease note:- gettjobs recruitment firm does not charge any fee of any kind from anyone to apply with us or to get a job offer post successful selection.Interested candidates can call or whatsapp hr sara: 8667076523 Drop your cv to sara@gettjobs.comRefer your friends as well

Keyskills :
reading comprehensionbusiness analysiscomputer proficiencyicsr processingpharmaclinical researchmedical recordsunstructured datacase processingbscsowadverse eventslife cycle planningdrug safetyadverse event reportingvaccinespharmacovigilan

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