Chief Medicine Safety Specialist

6 days ago


Hyderabad, Telangana, India beBeeMedical Full time ₹ 18,00,000 - ₹ 2,02,50,000

Job Title: Senior Medical Safety Advisor

Role Summary:

The Senior Medical Safety Advisor is a key position within our organization, responsible for providing medical expertise in the evaluation of safety data from various sources. This includes determining the medical and scientific relevance of serious adverse event reports within the context of a product's safety profile.

This role involves participating in matrix management activities, including evaluating safety issues and preparing aggregate reports. The successful candidate will have a strong background in medicine and pharmacovigilance, with experience in managing safety data and collaborating with cross-functional teams.

Key Responsibilities:

  • Conduct medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
  • Compose and medically review Analyses of Similar Events (AOSE) for expedited cases
  • Provide coding reviews of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings
  • Act as an internal consultant to pharmacovigilance case processing teams on projects being supported
  • Perform medical safety reviews of protocols, Investigative Brochures, and/or Case Report Forms (CRFs) for appropriate safety content and data capture
  • Provide aggregate reviews of safety information, including clinical data, post marketing, literature review, and observational studies
  • Ensure timely service delivery from productivity, compliance, and quality perspectives
  • Lead and participate in initiatives for timely service delivery
  • Provide therapeutic area/pharmacovigilance issue guidance and lead/managing other safety team members in single case assessment
  • Ensure update of watch lists, expectedness, labeling lists/RSIs, and develop additional capabilities within the team
  • Lead, drive, and participate in training activities, product transitions, audit preparation, and knowledge exchange initiatives
  • Review and sign off on Project Safety Plans and Medical Monitoring Plans per medical safety scope agreed in contract
  • Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings


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