5 - 10 years
4 - 7 Lacs
Posted:8 hours ago|
Platform:
Work from Office
Full Time
Role Overview:
We are seeking a Study Director with proven experience in Safety Pharmacology to lead end-to-end studies in compliance with GLP and regulatory guidelines. The candidate should have prior CRO experience and be fully capable of independently designing study protocols, executing studies, and delivering comprehensive reports to clients.
Key Responsibilities:Protocol Design: Develop scientifically sound and regulatory-compliant protocols for CNS, CVS, respiratory safety pharmacology studies, and hERG assay.Study Conduct: Oversee and ensure accurate execution of studies, coordinating with technical staff and laboratory teams.Data Analysis & Interpretation: Review raw data, perform analysis, and draw meaningful conclusions aligned with regulatory requirements.Reporting: Prepare and finalize comprehensive study reports; ensure timely submission to clients.Client Interaction: Act as primary point of contact for sponsors; present study design, interim updates, and final results.Compliance & Quality: Ensure adherence to GLP, ICH S7A/S7B, and OECD guidelines; support audits and regulatory inspections.Desired Profile:PhD / Masters in Pharmacology, Toxicology, or related field.
Vivo Bio Tech
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