Pharmacovigilance Services Assoc Manager

Skill required: Pharmacovigilance Operations - Pharmacovigilance Drug Safety Surveillance

Designation: Pharmacovigilance Services Assoc Manager

Qualifications:Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences

Years of Experience:10 to 14 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do Oversee and ensure adherence to Quality Management Framework procedures that is required in delivering high quality cases and managing the teams performance

What are we looking for Educational:Bachelorsdegree in health sciences or related fields; or equivalent combination in educational credential and experience.Experience RequirementsGeneral understanding of ICH, GCP, FDA, MHRA and similar requirements with respect of pharmacovigilanceHigh degree of accuracy and attention to detailGood technical knowledge of medical terminologyGood verbal and written communication skillsStrong interpersonal skills within the teamBasic 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 maintenanceMonitoring, tracking and reconciliation of client mailboxes and SharePoint as applicable.To request relevant access, tool, databases, Software Applications etc. as applicableTo provide relevant approval as per SOP/SWITo 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.
Qualification
Bachelor of Aryurvedic Medicine And Surgery,Bachelor Degree in Life Sciences,Master Degree in Life Sciences