Job Posting: Team Member – Clinical/Pre-Clinical/BABE (79819)
Requisition ID: 79819
Location: Vikhroli, Maharashtra, India
About the Company:
Our company, based in Vikhroli, Maharashtra, is a leading pharmaceutical organization committed to improving the quality of life through innovative healthcare solutions. With a strong emphasis on research and development, we strive to bring safe and effective pharmaceutical products to market.
Employment Type: Permanent
As a Team Member, your role will involve executing, monitoring, reporting, and interpreting preclinical, clinical, and BABE studies at CROs (Contract Research Organizations). You will be responsible for supporting various regulatory submissions within targeted timelines, budgets, quality, and regulatory guidelines. Additionally, you will identify health hazards and assess risks associated with pharmaceuticals, chemicals, intermediates, impurities, etc. through toxicological review and derivation (only for preclinical studies).
- Gather preclinical/ clinical/ BABE study outline data: Understand specific regulatory requirements and project constraints to ensure successful conduct of studies/trials cost-effectively and within timelines.
- Check CROs for conducting studies: Visit CROs or evaluate them for site feasibility, selection, and adequacy of facility, skill, and experience necessary for conducting preclinical/ clinical/ bioequivalence studies.
- Liaise with CROs and internal team: Enable preparation, review, and finalization of study protocols as per the defined strategy. Ensure approval of protocols by all relevant stakeholders, Ethics Committee, and/or Regulatory authorities within targeted timelines.
- Ensure procurement and dispatch of samples: Procure and dispatch Innovator samples, reference listed drug (RLD), and ensure availability of test formulation along with relevant documents prior to study initiation.
- Monitor and/or audit ongoing studies: Ensure satisfactory conduct of studies at CROs, adhering to guidelines, regulatory requirements, study-specific instructions, and project timelines.
- Project coordination: Act as the project coordinator, liaising with internal team members, cross-functional teams, CROs, and Project Managers. Align all stakeholders for the successful execution of bioequivalence studies.
- Identify health hazards and assess risk: Conduct toxicological review and derivation of PDE (permitted daily exposure), OEL (occupational exposure limit), TTC (Threshold of toxicological concern) for pharmaceuticals, chemicals, intermediates, impurities, etc. (only for the preclinical team).
- For BABE: B. Pharm/B.Sc.
- For Clinical: B. Pharma or M.Sc. or M.B.B.S.
- For Preclinical: B. V. Sc. & A.H is compulsory. M. V. Sc. (Pharmacology and Toxicology) is desirable.
Relevant Work Experience
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.
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Vikhroli
Apply for this position here.
Keywords: Team Member, Clinical, Pre-Clinical, BABE, Permanent, Pharmaceutical, CROs, Regulatory Submissions, Toxicological Review, Risk Assessment