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
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