Medical Safety Expert

7 days ago

Solapur, Maharashtra, India beBeeMedical Full time ₹ 18,00,000 - ₹ 24,00,000
Senior Medical Safety Advisor

This position plays a pivotal role as a senior technical leader in the field of pharmacovigilance. The Senior Medical Safety Advisor is responsible for providing medical expertise in evaluating safety data from various sources as part of the overall pharmacovigilance process.

The key responsibilities of this role include:

  • Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
  • Composing, editing, and medically reviewing Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements
  • Providing coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
  • Serving as an internal consultant to pharmacovigilance case processing teams on projects being supported
  • Performing medical safety review of protocols, Investigative Brochures, and/or Case Report Forms (CRFs) for appropriate safety content and data capture
  • Providing aggregate reviews of safety information to maintain oversight of a product's safety profile
  • Ensuring service delivery from productivity, compliance, and quality perspectives within regulatory/contracted timelines
Qualifications and Requirements
  • MBBS OR MD from an accredited and internationally recognized medical school
  • Three plus years of experience practicing clinical medicine after award of medical degree
  • Two plus years of pharmacovigilance experience
  • In-depth knowledge of global, regional, and local clinical research regulatory requirements
  • Skill in use of multiple safety databases
  • Adequate Computer skills, especially Microsoft word, excel & PowerPoint

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