Are you a dynamic professional eager to make an impact in the pharmaceutical industry? Join our esteemed organization as a Team Member – Clinical/Pre-Clinical/BABE based in Vikhroli, Maharashtra. This role offers an excellent opportunity to grow and contribute to innovative regulatory submissions and cutting-edge studies.
About the Company
Our organization is at the forefront of the pharmaceutical industry, renowned for its commitment to excellence, innovation, and quality. We specialize in developing and delivering reliable healthcare solutions, ensuring regulatory compliance, and maintaining industry-leading standards.
Key Responsibilities
As a Team Member – Clinical/Pre-Clinical/BABE, your role involves:
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- Study Execution:
- Designing and monitoring preclinical, clinical, and bioequivalence studies in collaboration with Contract Research Organizations (CROs).
- Ensuring alignment with regulatory guidelines and project timelines.
- CRO Evaluation:
- Conducting site feasibility visits to assess CRO capabilities, infrastructure, and expertise.
- Protocol Management:
- Collaborating with stakeholders to prepare and finalize study protocols for approval by Ethics Committees and regulatory bodies.
- Resource Coordination:
- Procuring and dispatching required materials, such as innovator samples, test formulations, and relevant documents.
- Study Monitoring:
- Overseeing studies to ensure compliance with regulatory and project-specific requirements.
- Auditing ongoing studies for quality assurance.
- Project Coordination:
- Acting as the liaison between internal teams, CROs, and project managers to ensure seamless execution.
- Risk Assessment:
- Evaluating potential health hazards and deriving permissible exposure limits for pharmaceuticals and chemicals (specific to the preclinical team).
Qualifications
To excel in this role, you must possess:
- Education:
- BABE Studies: B. Pharm/B.Sc.
- Clinical Research: B. Pharma or M.Sc., MBBS, B.V.Sc. & A.H.
- Preclinical: M.V.Sc. (Pharmacology and Toxicology) is desirable.
- Experience:
- At least 2 years of experience in BA/BE, clinical research operations, or preclinical pharmacology and toxicology.
Essential Skills
- Technical Expertise: Comprehensive knowledge of regulatory guidelines and hands-on experience with pharmacology and toxicology practices.
- Soft Skills:
- Collaboration and teamwork
- Innovation and agility
- Accountability and empathy
- Effective communication and people management
