Arcolab Hiring for Compliance Monitoring Team – Clinical Trials, Pharmacovigilance Preferred

Arcolab is seeking dedicated professionals to join our Compliance Monitoring Team in Bangalore. This exciting opportunity is ideal for individuals with experience in clinical trials, pharmacovigilance, or quality management systems. If you have a strong understanding of regulatory guidelines and quality control processes, we want to hear from you!

Location: Bangalore
Company: Arcolab
Experience: 1 to 3 years

Job Description

Please find the JD below for your reference

• Assist in implementing a compliant quality management system for clinical trials.
• Monitor the quality compliance of Clinical Trials, Bioavailability, and Bioequivalence Organization.
• Conduct compliance reviews and identify process improvements/optimizations in Pharmacovigilance (PV) and Clinical operations.
• Provide support to the Medical Affairs team with the interpretation of regulatory guidelines.
• Enter information into tracking tools to analyse trends on compliance reviews.
• Assist in the preparation and review of SOPs for Clinical Trials, BA/BE, and PV.
• Conduct quality control reviews of key trial documents, including protocols, informed consent forms, clinical study reports, and investigator brochures.
• Perform quality control reviews of PV processes such as ICSR, aggregate reports, and signal reports.
• Assist in external and internal audit preparation activities.
• Support risk management activities related to the Medical Affairs function.
• Assist in implementing and ensuring compliance with ISO 27001 and ISO 27701 standards.

Qualifications:

• Bachelor’s degree in a related field (e.g., Life Sciences, Pharmacy, Clinical Research).
• Experience in clinical trials, pharmacovigilance, or quality management systems is preferred.
• trong understanding of regulatory guidelines and quality control processes.
• xcellent organizational and communication skills.
• bility to work independently and as part of a team.
• ttention 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.