Expert Clinical Safety Specialist

3 days ago

Rajkot, Gujarat, India beBeeSenior Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Medical Review Team Lead

We are seeking an experienced Medical Review Team Lead to join our organization.

Clinical Phase:

  • Lead a team of medical reviewers in all aspects of clinical and post-marketing drug safety.
  • Collaborate with clients to ensure effective communication and resolution of queries and protocol deviations.
  • Review and provide feedback on study protocols as needed.
  • Develop and deliver therapeutic area training for case processing teams.
  • Ensure compliance with GCP and GVP requirements.

Post-Marketing (Pharmacovigilance):

  • Support the maintenance of medical platforms, including SOPs, manuals, and documents.
  • Lead and support medical reviewers in their work.
  • Interact with client medical teams and clinical teams.
  • Act as a main point of contact for client concerns and escalations.
  • Conduct medical reviews of ICSRs, including spontaneous and literature reports.
  • Support causality assessment, medical evaluation, and benefit-risk evaluation of medicinal products.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
  • Provide feedback and ongoing workshops to develop medical reviewers.
  • Participate in audits and inspections as required.
  • Ensure understanding of client needs, conventions, and expectations are met and exceeded.

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' 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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