Post : Team Member – Clinical/Pre-Clinical/BA-BE
Job Description
Job Purpose
Execute, monitor, report and interpret preclinical, clinical and BABE studies at CROs to support various regulatory submissions within targeted timelines, budgets, quality and regulatory guidelines; identify health hazard and assess risks associated with pharmaceuticals/ chemicals/ intermediates/ impurities, etc. by toxicological review and derivation (Only for preclinical)
Accountabilities
I. Gather preclinical/ clinical/ BA-BE study outline data by understanding the specific regulatory requirements and project constraints to ensure successful conduct of studies/trials cost effectively and within timelines
II. Check CROs for conducting preclinical/ clinical/ bio equivalence studies by site feasibility/ selection visits or evaluation for ensuring adequate facility, skill and experience for conducting the studies as per requirements
III. Liaise with CROs and internal team to enable preparation, review, and finalization of study protocol as per the defined strategy to ensure that protocol is approved by all relevant stakeholders, Ethics Committee, and/or Regulatory authorities within targeted timelines
IV. Ensure procurement and dispatch of Innovator samples/ RLD and availability of test formulation along with relevant documents (like COA, GMP statements, batch size information etc.) before study initiation
V. Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements (guidelines, regulatory, study specific, etc.) and project timelines
VI. Act as the project coordinator for the entire study by liaising with internal team members, cross-functional teams, CROs and Project Managers to align all stakeholders and successfully conduct the BE study
VII. Identify health hazard and assess risk of pharmaceuticals/ chemicals/ intermediates/ impurities, etc. by toxicological review and derivation of PDE (permitted daily exposure)/ OEL (occupational exposure limit)/ TTC (Threshold of toxicological concern) for pharmaceuticals/ chemicals – (only for preclinical team)
Candidate Profile
B. Pharm/B.Sc. for BABE and For clinical B. Pharma or M.Sc. Or M.B.B.S.B. V. Sc. & A.H is compulsory. M. V. Sc. (Pharmacology and Toxicology) is desirable for preclinical
2 years of experience in handling BA/ BE or Clinical Research operations with knowledge of regulatory guidelines; 2 years of experience in preclinical pharmacology and toxicology with minimum 2 years of practical experience
Additional Information
Experience : 2 years
Qualification : B. Pharm/B.Sc. for BABE and For clinical B. Pharma or M.Sc. Or M.B.B.S.B. V. Sc. & A.H is compulsory. M. V. Sc. (Pharmacology and Toxicology) is desirable for preclinical
Location : Maharashtra – Vikhroli
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical/Pre-Clinical/BABE
End Date : 20th July 2024