Senior Medicinal Science Expert

2 days ago

Kota, Rajasthan, India beBeeMedical Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

Job Title: Senior Medical Safety Advisor

Role Overview:

To provide medical expertise in the evaluation of safety data from various sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of a product's safety profile.

Key Responsibilities:

  • Conduct thorough medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality, and company summaries.
  • Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
  • Provide coding reviews 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 reviews of protocols, Investigative Brochures, and/or Case Report Forms (CRFs) for suitable safety content and data capture, as applicable.
  • Provide aggregate reviews of safety information, including clinical data, post-marketing, literature reviews, and observational studies, to maintain oversight of a product's safety profile.
  • Evaluate service delivery from productivity, compliance, and quality perspectives within regulatory/contracted timelines.

Required Skills and Qualifications:

  • A MBBS or MD degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is essential.
  • Three plus years of experience practicing clinical medicine after awarding a medical degree, with graduate and/or residency training required.
  • Two plus years of pharmacovigilance experience is necessary.

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