Location: Vikhroli, Maharashtra, India
Req ID: 86072
Division: IPD
Department: IPD
Employment Type: Permanent
Job Purpose
- Execute, monitor, report, and interpret preclinical, clinical, and BABE studies at CROs.
- Support various regulatory submissions within targeted timelines, budgets, quality, and regulatory guidelines.
- Identify health hazards and assess risks associated with pharmaceuticals/chemicals/intermediates/impurities through toxicological review and derivation (only for preclinical).
Key Responsibilities
- Study Data Collection: Gather preclinical, clinical, and BABE study outline data by understanding specific regulatory requirements and project constraints to ensure successful conduct of studies/trials cost-effectively and within timelines.
- CRO Evaluation: Check CROs for conducting preclinical, clinical, and bioequivalence studies through site feasibility/selection visits or evaluation to ensure adequate facilities, skills, and experience.
- Protocol Preparation: Liaise with CROs and internal teams to enable preparation, review, and finalization of study protocols as per the defined strategy, ensuring approval by all relevant stakeholders, Ethics Committees, and/or Regulatory authorities within targeted timelines.
- Sample Procurement: Ensure procurement and dispatch of Innovator samples/RLD and availability of test formulations along with relevant documents (like COA, GMP statements, batch size information, etc.) before study initiation.
- Study Monitoring: Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements (guidelines, regulatory, study-specific, etc.) and project timelines.
- Project Coordination: 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.
- Health Hazard Identification: Identify health hazards and assess risks of pharmaceuticals/chemicals/intermediates/impurities through 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).
Qualifications
- Education:
- B. Pharm/B.Sc. for BABE
- B. Pharm or M.Sc. or M.B.B.S for clinical
- B. V. Sc. & A.H is compulsory for preclinical
- M. V. Sc. (Pharmacology and Toxicology) is desirable for preclinical
- Experience:
- Minimum 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 a minimum of 2 years of practical experience
Skills and Competencies
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Vikhroli, Maharashtra, India
