Career for Pharmacy professionals to join in ICMR as Consultant

 

The lndian Council of Medical Research (ICMR), New Delhi, the apex body in lndia for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. The Govt. of India through lndian Council of Medical Research (ICMR) has initiated its flagship program by establishing an "lndian TB Research Consortium" to advance technology and product development by harnessing interdisciplinary expertise and regional complementary strengths and focus on building and strengthening scientific capabilities and generating a better understanding to aid accelerating the development of new diagnostics, new & improved vaccines and immunotherapies, drugs for TB.

Post : Consultant (Scientific) Biomedical Research (Quality Assurance)

Essential Qualifications
Post Graduate Degree (MD/MS/DNB) with one year of demonstrated experience of clinical research in Quality assurance

OR

Post Graduate Diploma in clinical research after MBBS /BAMS with 2years of demonstrated experience in clinical research in Quality assurance

OR

Ist class Masters (MSc/ M.Pharma) in medical Pharmocology/Biotechnology/Clinical Research/Microbiology/Biochemistry with 4-6 years demonstrated experience in clinical research in Quality assurance

Desirable
• Demonstrated experience in Quality Assurance for the clinical research
• Evaluating quality events, incidents, queries and complaints and handling compliance issues.
• Experience in managing and maintaining databases for quality systems.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct with a recognized GCP certification.

Age : Limited as on date : up to 70 years

Nature of Duties
• Develop and maintain Quality management system as relevant for clinical trial
• Review of IND, Dossier submission
• Create, Conduct, Maintain and control documents, forms, SOPs and Templates consistent with the organizational procedures.
• Development and manage audit program for clinical studies.
• Monitor and advocate improvement in compliance with ICH-GCP guidelines.
• Co-ordinate/Conduct and report system, vendor and site audits. Perform additional audits as required for laboratories (clinical/immunology)
• Train and mentor clinical research team on latest guidelines and regulations
• Facilitate regulatory inspections including those at sites.
• Keep upto date with all quality and compliance issues.
• The job may require frequent travel to all study sites for quality

Consolidated Emoluments : Maximum Rs. 70,000/- per month depending upon experience and knowledge.

Tenure : Two Years

Syllabus for written examination : Degree level related to project work, if Written Test conducted

Place of work : ICMR/DHR Hqrs., New Delhi

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