Pharmacovigilance Services Analyst
About The Role
Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation
Pharmacovigilance Services Analyst
Qualifications
Bachelor of Aryurvedic Medicine And Surgery
Bachelor Degree in Life Sciences
Master Degree in Life Sciences
Years of Experience
3 to 5 years
What would you do?
Oversee and ensure adherence to Quality Management Framework procedures that is required in delivering high quality cases and managing the team??s performance.
What are we looking for?
• Bachelors degree in health sciences or related fields; or equivalent combination in educational credential and experience.
• General understanding of ICH, GCP, FDA, MHRA and similar requirements with respect of pharmacovigilance.
• High degree of accuracy and attention to detail.
• Good technical knowledge of medical terminology.
• Good verbal and written communication skills.
• Strong interpersonal skills within the team.
• Basic Excel, Word and PPT.
Roles and Responsibilities
• Ensure compliance to the Pharma Quality Management framework procedures by reviewing the Quality Management system of the project and suggesting improvements.
• Collaborating with Team leads, Trainers and Medical Reviewers in the engagement to implement new processes/enhance existing processes while ensuring compliance to quality standards.
• Coordinate with the Quality reviewers to ensure compliance to the Quality Management framework procedures.
• Review late logs generated by the Client and update Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA) as required or reassign the late logs to other functional stake holders as needed.
• Follow up with all functional stake holders to ensure that the late logs are documented as per timelines in the applicable Client SOP.
• Ensure trainings, awareness sessions, refresher trainings/workshops are conducted for the team to understand case processing conventions.
• Work with the Capability development Lead and Operational Excellence team to improve the quality process of the engagement.
• Ensure the Quality control process is in place by identifying gaps and learning opportunities.
• Collaborate with the Client Quality/Training teams in sharing best practices, identifying gaps and fostering knowledge transfer, through effective communication.
• Essential duties include drafting agendas and meeting minutes; accurately archiving applicable documents; reviewing safety case data and other documents for completeness and accuracy.
• Tracking, submitting, and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections.
• Ensure proper documentation of the RCA and CAPA for quality issues as outlaid in the processes.
• Drive zero quality issues leading to late submissions to the regulatory authority.
• Ensure the engagement meets the SLAs pertaining to Quality every month.
• Support SOP development and maintenance.
• Monitoring, tracking and reconciliation of client mailboxes and SharePoint as applicable.
• To request relevant access, tool, databases, Software Applications etc. as applicable.
• To provide relevant approval as per SOP/SWI.
• To perform assist and contribute in transition related activities as per the client requirement.
• To monitor, review and reconcile client tool/databases and identify if any discrepancy noted/noticed and troubleshoot the same.
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Apply To this Job
Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation
Pharmacovigilance Services Analyst
Qualifications
Bachelor of Aryurvedic Medicine And Surgery
Bachelor Degree in Life Sciences
Master Degree in Life Sciences
Years of Experience
3 to 5 years
What would you do?
Oversee and ensure adherence to Quality Management Framework procedures that is required in delivering high quality cases and managing the team??s performance.
What are we looking for?
• Bachelors degree in health sciences or related fields; or equivalent combination in educational credential and experience.
• General understanding of ICH, GCP, FDA, MHRA and similar requirements with respect of pharmacovigilance.
• High degree of accuracy and attention to detail.
• Good technical knowledge of medical terminology.
• Good verbal and written communication skills.
• Strong interpersonal skills within the team.
• Basic Excel, Word and PPT.
Roles and Responsibilities
• Ensure compliance to the Pharma Quality Management framework procedures by reviewing the Quality Management system of the project and suggesting improvements.
• Collaborating with Team leads, Trainers and Medical Reviewers in the engagement to implement new processes/enhance existing processes while ensuring compliance to quality standards.
• Coordinate with the Quality reviewers to ensure compliance to the Quality Management framework procedures.
• Review late logs generated by the Client and update Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA) as required or reassign the late logs to other functional stake holders as needed.
• Follow up with all functional stake holders to ensure that the late logs are documented as per timelines in the applicable Client SOP.
• Ensure trainings, awareness sessions, refresher trainings/workshops are conducted for the team to understand case processing conventions.
• Work with the Capability development Lead and Operational Excellence team to improve the quality process of the engagement.
• Ensure the Quality control process is in place by identifying gaps and learning opportunities.
• Collaborate with the Client Quality/Training teams in sharing best practices, identifying gaps and fostering knowledge transfer, through effective communication.
• Essential duties include drafting agendas and meeting minutes; accurately archiving applicable documents; reviewing safety case data and other documents for completeness and accuracy.
• Tracking, submitting, and distributing of reports; assisting liaisons with the partners and cross-functional team members to ensure compliance; supporting various ad-hoc deliverables or pharmacovigilance projects; and participating in audits and inspections.
• Ensure proper documentation of the RCA and CAPA for quality issues as outlaid in the processes.
• Drive zero quality issues leading to late submissions to the regulatory authority.
• Ensure the engagement meets the SLAs pertaining to Quality every month.
• Support SOP development and maintenance.
• Monitoring, tracking and reconciliation of client mailboxes and SharePoint as applicable.
• To request relevant access, tool, databases, Software Applications etc. as applicable.
• To provide relevant approval as per SOP/SWI.
• To perform assist and contribute in transition related activities as per the client requirement.
• To monitor, review and reconcile client tool/databases and identify if any discrepancy noted/noticed and troubleshoot the same.
Apply tot his job
Apply To this Job