Senior Medical Reviewer

2 days ago

Gandhinagar, Gujarat, India beBeeMedicalAdvisor Full time ₹ 20,00,000 - ₹ 25,00,000

We are seeking a highly skilled Medical Advisor to lead our medical review teams. This is an excellent opportunity for a seasoned professional with expertise in clinical and post-marketing drug safety.

Clinical Phase:

  • Lead as a medical monitor/medical expert
  • Medical monitoring experience is a must, and the ability to effectively communicate with clients, attend investigator meetings as required, and provide support to sites regarding protocol or possible drug interactions is essential.
  • Review and provide feedback on study protocols as needed.
  • Deliver therapeutic area training for all case processing team members.
  • May require 24/7 availability depending on client needs for possible queries or protocol deviations resulting in potential harm to patients.
  • Drafting medical monitoring plans (MMP) and ensuring compliance.
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
  • Make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensure protocol compliance, and draft monthly reports for clients (with presentation at periodic meetings if required).
  • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance):

  • Support in maintenance of medical platform including SOPs, manual, and documents.
  • Lead and support medical reviewers.
  • Interaction with the clients' medical team and clinical team.
  • Act as the main responsible person at PLG for clients' concerns and escalation.
  • Medical review of the ICSRs (e.g., Spontaneous, literature).
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
  • Provide feedback and ongoing workshops to develop the medical reviewers.
  • Participate in audits and inspections as required.
  • Ensure understanding of client needs, conventions, and ensure expectations are met and exceeded.
  • Training and mentoring other team members.

Required education: MBBS, or MD (Doctor of Medicine)

Required experience:

  • Experience in leading medical review teams.
  • Client communications.
  • Safety Database experience.
  • 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.

Required technical skills:

  • Microsoft package.
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
  • Working knowledge of EDC systems.
  • Good Medical knowledge and Pharmacology understanding.

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