Cipla BPharma Team Member Job Opening – Apply Online
Team Member – Clinical/Pre-Clinical/BABE
Posting Date: 29 Jul 2024
Country: India
State: Maharashtra
Location: Mumbai
Req Id: 85826
Division: IPD
Department: IPD
Employment Type: Permanent
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/BABE 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/bioequivalence 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)
Education 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
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
Competencies/Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Mumbai
Link to apply: Apply Here
Keywords: Team Member, Clinical, Pre-Clinical, BABE, Job Posting, Mumbai, Cipla, Regulatory Guidelines, Pharmacology, Toxicology. Cipla BPharma Team Member Job Opening – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
