Clinical Safety Specialist

3 days ago


India beBeeMedicalExpert Full time ₹ 90,00,000 - ₹ 1,20,00,000
Medical Expert

We are seeking an experienced medical professional to lead our clinical and post-marketing drug safety team.

This role requires expertise in all aspects of medical monitoring, including protocol review, therapeutic area training, and adverse event reporting.

Clinical Phase:
  • The successful candidate will be responsible for leading clinical trials and ensuring compliance with GCP and FDA regulations.
  • They will need to effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions.
  • Reviewing study protocols and providing feedback is also an essential part of this role.
Post-Marketing (Pharmacovigilance):
  • The candidate will support the maintenance of our medical platform, including SOPs, manuals, and documents.
  • They will lead and support medical reviewers in their work, interacting with clients' medical teams and clinical teams.
  • Act as the main point of contact for client concerns and escalations.

Required education: MBBS or MD (Doctor of Medicine)

Required experience:

  • Experience in leading medical review teams
  • Client communications
  • Safety Database experience
  • Minimum 10 years of experience working for 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

This challenging role requires a high level of expertise and professionalism. If you have the necessary skills and experience, we encourage you to apply.



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