Chief Medical Officer

1 week ago

Rajahmundry, Andhra Pradesh, India beBeeMedical Full time ₹ 20,00,000 - ₹ 25,00,000

We are seeking an experienced Medical Advisor to lead our team in clinical and post-marketing drug safety.

Clinical Phase:

  • As a medical monitor, you will be responsible for leading medical monitoring teams, providing medical expertise, and ensuring protocol compliance.
  • You will effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions.
  • Your duties will include reviewing and providing feedback on study protocols, delivering therapeutic area training, and drafting medical monitoring plans (MMP).
  • You may be required to work 24/7 depending on client needs for queries or protocol deviations resulting in potential harm to patients.
  • Key responsibilities include reviewing adverse events (AEs), assessing their severity, and determining appropriate actions, as well as making assessments on SUSAR reportability.
  • You will also perform reviews and interpret clinical data, ensure protocol compliance, and draft monthly reports for clients (with presentations at periodic meetings if required).
  • Maintenance of medical platforms, including SOPs, manuals, and documents, is another key responsibility.

Post-Marketing (Pharmacovigilance):

  • You will support the maintenance of medical platforms, interact with clients' medical teams and clinical teams, and act as the main point of contact for clients' concerns and escalations.
  • Responsibilities include medical review of ICSRs (e.g., Spontaneous, literature), supporting causality assessments, medical evaluations, benefit-risk evaluations of medicinal products, and mentoring junior medical reviewers.
  • You will also participate in audits and inspections as required, ensure understanding of client needs, conventions, and expectations, and train and mentor other team members.

Education: MBBS or MD (Doctor of Medicine)

Experience:

  • 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

Tech 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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