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Medical Advisor Or Medical Monitor

Job Description:

1. Primary Purpose:

  • Helps Sponsor with local medical practice, regulatory issues, and operational considerations when developing/ finalizing protocols
  • Medical Advisor optimizes the function of the Operations Team. Their primary responsibilities include (but are not limited to):
  • Providing input on clinical development plans, protocol design, and risk assessments. Reviewing and analyzing safety and efficacy trends,
  • Reviewing all study team deliverables, such as final narratives and clinical study reports, Providing therapeutic and project specific training.

2. Major accountabilities of position

  • Ensures effective communication with PIs, medical monitors of the sponsors for smooth execution of medical monitoring responsibilities.
  • Travels (internationally also) to participate in meetings with Sponsor, to IMs, to sites and to RAs/Has
  • Attends meetings (Regulatory, IM, site initiation, monitoring) to ensure active participation and imparts training on protocol, safety reporting, scales and procedures (therapeutic area based).
  • Reviews and advises corrective steps to data management on medical related queries.
  • Prepares plan such as medical monitoring, reviews plan such study plan, data management plans etc
  • Ensures effective documentation of all activities related to medical monitoring.
  • Responds to EC, investigator and regulatory queries pertaining to medical issues, sponsors queries on safety and efficacy issues
  • Prepares/provides inputs to SOPs (including medical and pharmacovigilance).
  • Helps PVG team in timely and effective reporting of serious adverse event (SAE)/adverse drug reaction (ADR) to applicable regulatory authorities.
  • Ensures appropriate medical interpretation and consistency are applied to adverse event case assessment, where applicable.
  • Serves as scientific / medical mentor for the team.

3. Work relations (context – main interfaces – functional report)

  • Reports to Director – Medical Affairs.
  • Interacts with monitoring team, QA, Sites, Sponsors

4. Travel Requirement

  • Travelling nationally and internationally is an absolute requirement (up to 20%)

5. Skills, experience and qualifications required for the job

  • Qualifications: MD/DNB in Psychiatry preferred /MBBS with proven experience in Psychiatry / Neurology
  • Experience: 3- 4 years of experience in clinical psychiatry with focus on inpatient / outpatient management of major mental disorders. Good practical experience of various Psychopharmacological molecules.
  • Skills: Analytical ability, Teamwork, effective Interpersonal skills, decision making capability.
  • Knowledge of psychopharmacological products

Medical Advisor Or Medical Monitor