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.

Requirements

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.