Job Description:
- Assist in implementing a compliant quality management system for clinical trials.
- Monitor quality compliance of Clinical Trials, Bioavailability, and Bioequivalence Organization.
- Conduct compliance reviews and identify process improvements in Pharmacovigilance (PV) and Clinical operations.
- Support Medical Affairs team in interpreting regulatory guidelines.
- Enter data into tracking tools to analyze compliance trends.
- Assist in preparing and reviewing SOPs for Clinical Trials, BA/BE, and PV.
- Perform quality control reviews of key trial documents and PV processes.
- Prepare for external and internal audits.
- Support risk management activities related to Medical Affairs.
- Implement and ensure compliance with ISO 27001 and ISO 27701 standards.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or related field.
- Experience in clinical trials, pharmacovigilance, or quality management systems preferred.
- Strong understanding of regulatory guidelines and quality control processes.
- Excellent organizational and communication skills.
- Ability to work independently and collaboratively.
- Attention to detail and strong analytical skills.
How to Apply: Interested candidates should submit their resume and a cover letter detailing their qualifications and experience to Dev.kiran@arcolab.com.
