Careers

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

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Medical Advisor Or Medical Monitor