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Safety Surveillance Specialist/Physician

Full Time

Bengaluru, India

Hyderabad, India

Work Remotely, India

Description

Job Responsibilities :

  • Perform medical interpretation of safety data with client oversight.
  • Retrieve, analyze and interpret data from multiple sources (client systems, clinical trials, safety databases, literature, etc.).
  • Determine and document the impact of identified safety issues on benefit-risk profile of affected client product(s).
  • Lead authoring of assessment for identified signals as directed by client.
  • Support the preparation of presentations of safety data and related information for client leadership and safety governance committees.
  • Lead authoring of assigned sections of client Safety deliverables.
  • Lead or support the preparation of regulatory safety requests.
  • Other routine safety duties as assigned by client.
  • Signal Detection and Assessment.
  • Interpretation, summarization, and presentation of data and assigned safety deliverable documents.
  • Assigned sections of client safety deliverable documents such as DSUR,PSUR,PADER,ACO,RMP,Clinical Overview,CSS,HHA.

Candidate Profile :

  • Candidate should be M.Pharm, BDS, MDS, MBBS, MSc in Life Sciences.
  • Should have 2-6 years of experience in Signal Management activities.
  • Strong verbal and written communication skills, with ability to communicate effectively internally and with clients.
  • Experience in Signal Detection, Signal Evaluation, and validation required.
  • Candidate should be able to work in US timezone.