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Senior Drug Safety Associate (Senior DSA) Bengaluru India,  

Navitas Life Sciences (company)


Posted on : 22 December 2017

Project Description

Category: Experienced (non-manager)
Location: Bangalore
Job Type:
Full Time
Education: Graduation / Post Graduation in Medical or Life Sciences

Job Description:


Responsibilities & functions:

Medical Project Management

  • Support in management of medical tasks during clinical trials and non-interventional studies (in cooperation with operational PM)
  • Support in management of drug safety tasks during clinical trials and non-interventional studies (in cooperation with operational PM)
  • Management of medical and drug safety standalone projects
  • Interface for sponsors

Medical Review

  • Support during the medical review of study documents in the preparation of projects (study outlines, synopsis, clinical trial protocols, observational plans of NIS, CRFs)
  • Support during the medical review of study documents at the end of projects (clinical trial reports, observational study reports, abbreviated reports, abstracts)
  • Support during the medical review of project plans for medical and safety standalone 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

  • Case narrative writing
  • Writing medical review summary reports / medical status reports
  • Support in writing the medical review / medical monitoring plans
  • Support in writing clinical trial protocols and observational plans of NIS
  • Support in writing clinical trial reports and observational study reports
  • Support in medical writing of scientific abstracts, scientific manuscripts, generation of congress posters

Medical Advice

  • Support in the medical coverage and advice during clinical trials and non-interventional studies (own staff, site staff, sponsor staff, IECs/IRBs)
  • Support in the medical, pharmacological and scientific advice; literature & guideline research

Pharmacovigilance

  • Safety management related to planning, conduct and evaluation of clinical trials and non- interventional studies
  • Medical review of adverse events, adverse drug reactions, pregnancy cases, lack of efficacy cases, overdose cases, and other special situations
  • Case handling/processing including control of reporting timelines
  • Writing, review, and distribution of aggregate safety reports (PSUR/PBRER, ASR, DSUR)
  • Post-authorization pharmacovigilance services (e.g. spontaneous cases, literature research, website screening)
  • Safety duties with safety database (e.g. Oracle ARGUS)
  • Reconciliation of safety data with Sponsor s Pharmacovigilance Department
  • Keeping drug safety legislation up-to-date
  • Training of procedures and processes in PV department EA
  • Writing and maintenance of necessary PV-SOPs and supportive documents
  • Keeping local PV records and files up-to-date in accordance with company procedures and local requirements
  • Preparation, participation, documentation of audits and inspections

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)
  • Experience in database handling, data entry (e.g. ARGUS)
  • 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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