Senior Medical Specialist

1 week ago

Kolkata, West Bengal, India beBeeMedical Full time ₹ 15,00,000 - ₹ 25,00,000

We are seeking a seasoned Medical Specialist to lead our medical review teams and oversee clinical and post-marketing drug safety.

Key Responsibilities:

  • Provide expert guidance as a medical monitor, overseeing all aspects of clinical trial monitoring.
  • Evaluate and provide feedback on study protocols, ensuring compliance with regulatory requirements.
  • Develop and deliver therapeutic area training for case processing teams and create medical monitoring plans (MMP).
  • Analyze adverse events reported by study sites, determining appropriate actions and assess SUSAR reportability.
  • Review and interpret clinical data, ensure protocol compliance and draft monthly reports for clients.
  • Update current training materials in line with GCP and GVP requirements for medical review of all cases.

Clinical Phase Objectives:

  • Lead and support the medical reviewers, interacting with client medical teams and clinical teams.
  • Act as main responsible person at PLG for client concerns and escalation.
  • Medical review of ICSRs (e.g., Spontaneous, literature) and support causality, medical assessment, benefit-risk evaluation of medicinal products.
  • Mentor junior medical reviewers, perform additional review of cases to ensure competency and provide feedback and ongoing workshops to develop medical reviewers.
  • Participate in audits and inspections as required.
  • Ensure understanding of client needs, conventions and ensure expectations are met and exceeded.
  • Train and mentor other team members.

Requirements:

  • Master's degree in Medicine or related field.
  • Minimum 10 years experience working for service providers or pharmaceutical companies.
  • At least 5-7 years of experience as a Medical Monitor or clinical phase.
  • Proven track record in leading medical review teams.

Skills:

  • Strong pharmaceutical background – deep knowledge of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Working knowledge of EDC systems.
  • Good medical knowledge and pharmacology understanding.
  • Microsoft package skills.

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