Senior Medical Safety Specialist

2 days ago

Nashik, Maharashtra, India beBeeMedical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Opportunity: Medical Safety Expert

Role Summary:

We are seeking a highly skilled Medical Safety Expert to provide medical expertise in the evaluation of safety data from various sources as part of the overall pharmacovigilance process.

Key Responsibilities:
  • Conduct thorough medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements
  • Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
  • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
  • Perform medical safety review of protocol, Investigative Brochure, 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 to maintain oversight of a product's safety profile
  • Ensure service delivery from productivity, compliance, and quality perspective within regulatory/contracted timelines
  • Lead and participate in initiatives taken for service delivery from team delivery perspective
  • Provide therapeutic area/pharmacovigilance issue guidance in leading/managing other safety team members in single case assessment
  • Ensure update of watch list, list of expectedness, labeling list/RSIs etc for assigned products and develop such 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 Plan and Medical Monitoring Plan 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
  • Act as Lead Safety Physician or additional team support and/or back up on assigned projects
Requirements:
  • MBBS OR MD from an accredited and internationally recognized medical school with curriculum relevant to general medical education required
  • Three plus years experience practicing clinical medicine after award of medical degree Graduate and/or Residency training required
  • Two plus years pharmacovigilance experience required
  • Sound knowledge of Medicine
  • In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements
  • Knowledge of Pharmacovigilance- ICSR
  • In-depth knowledge of departmental standard operating procedures (SOPs)
  • Skill in use of multiple safety databases
  • Adequate computer skills especially Microsoft word, excel & PowerPoint
  • Good communication skills verbal and written
  • Ability to establish and maintain effective working relationships with managers coworkers investigative site staff clients and regulatory agency representatives
  • A valid medical license or equivalent from country or region in which he/she resides and works preferred

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