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Drug Safety Associate (DSA) Bengaluru India,  

Navitas Life Sciences (company)


Posted on : 22 December 2017

Project Description

Category: Executive
Location: Bangalore
Job Type:
Full Time
Education: Graduation / Post Graduation in Medical or Life Sciences

Job Description:


Responsibilities & functions:

Medical Project Management

  • Assistance in management of medical tasks during clinical trials (in cooperation with operational PM)
  • Assistance in management of drug safety tasks during clinical trials (in cooperation with operational PM)
  • Assistance in management of medical and drug safety stand-alone projects

Medical Review

  • Support during the medical review of trial documents in the preparation of projects (study outlines, synopsis, trial protocols, CRFs)
  • Support during the medical review of trial documents at the end of projects (clinical trial reports, abbreviated reports, abstracts)
  • Support during the medical review of project plans for medical and safety stand-alone projects
  • Support during the medical review of data listings, validation of medical clinical study data, premature discontinuation cases and protocol deviations
  • Support during the generation of queries regarding medical issues / guidance and advice during data cleaning

Medical Writing

  • Assistance in writing the medical review / medical monitoring plans
  • Assistance in writing medical review summary reports / medical status reports
  • Assistance in medical writing of scientific abstracts, scientific manuscripts, generation of congress posters
  • Assistance in case narrative writing
  • Assistance in writing trial protocols
  • Assistance in writing clinical trial reports

Medical Advice

  • Assistance in the medical coverage and advice during trials (own staff, trial site staff, sponsor staff, IECs/IRBs)
  • Assistance in the medical, pharmacological and scientific advice; literature & guideline research

Pharmacovigilance

  • Support of safety management related to planning, conduct and evaluation of clinical trials
  • Support during medical review of serious adverse events and pregnancy cases
  • Support of writing and distribution of aggregate safety reports (PSUR, ASR, DSUR)
  • Support of post-authorization pharmacovigilance
  • Safety duties with safety database (e.g. Oracle AERS)

Preferred Skills:


  • Good understanding of medical matters
  • Good knowledge of GCP and pharmacovigilance principles and related guidelines and regulations
  • Good command of written and spoken English; additional languages favourable
  • Good knowledge of usual office software (MS Office: Word, Excel, Powerpoint)
  • Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability, commitment and capacity for team-work)
If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to: recruitment.bangalore@navitaslifesciences.com

Locations

Bangalore India

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