Senior Medical Expert Wanted

4 days ago

Delhi, Delhi, India beBeeMedical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Medical Professional Sought

We are looking for a seasoned medical professional to lead our clinical and post-marketing drug safety initiatives.

Clinical Phase:
  • Lead as a medical monitor, providing expertise in all aspects of clinical trials.
  • Collaborate with clients, attend investigator meetings, and provide support on protocol or possible drug interactions.
  • Review and provide feedback on study protocols as needed.
  • Deliver therapeutic area training for the case processing team.
  • Maintain 24/7 availability for client queries or protocol deviations that may impact patient safety.
  • Develop and ensure compliance with medical monitoring plans (MMP).
  • Assess and determine actions for adverse events reported by study sites.
  • Evaluate SUSAR reportability.
  • Interpret clinical data, ensure protocol compliance, and draft monthly reports for clients.
Post-Marketing (Pharmacovigilance):
  • Sustain medical platform integrity, including SOPs, manuals, and documents.
  • Lead and support medical reviewers.
  • Foster collaboration between clients' medical teams and clinical teams.
  • Manage client concerns and escalations as the primary point of contact.
  • Perform medical review of ICSRs (e.g., Spontaneous, literature).
  • Contribute to causality assessment, benefit-risk evaluation, and medicinal product reviews.
  • Mentor junior medical reviewers and perform additional review to ensure competency.
  • Provide ongoing workshops and feedback to develop medical reviewers.
  • Participate in audits and inspections as required.
  • Educate other team members on client needs, conventions, and expectations.
Qualifications

Required education: MBBS or MD (Doctor of Medicine)

Required experience:

  • Leadership experience in medical review teams.
  • Client communication skills.
  • Safety database experience.
  • A minimum of 10 years of experience working in service providers or pharmaceutical companies.
  • At least 5-7 years of experience as a Medical Monitor or in clinical phases.

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, and causality assessment.
  • Working knowledge of EDC systems.
  • Good medical knowledge and pharmacology understanding.

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