Skill required:
Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation:
Pharmacovigilance Services Specialist
Qualifications:
Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences
Years of Experience:
7 to 11 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 Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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 responsibilities in delivering service to the client including mobilization of resources required in delivering the service and managing their performance. Work closely with the client project lead and service delivery lead to manage risks, issues, and escalations and drive successful project completion with high quality.
What are we looking for?
Educational and Experience Requirements:
- Graduate in life sciences.
- Good understanding of Patient/Drug safety, Individual Case Safety Reports and Global Regulatory requirements.
- Creative approach to problem solving and good lateral thinking skills.
- High energy and drive to lead large teams.
- Comfortable working in a dynamic business environment
- Sound Communication Skills and Analytical Ability.
- Strong interpersonal and leadership skills.
- Ability to work independently under tight time constraints.
- Other essential duties include drafting pharmacovigilance agendas and meeting minutes; accurately archiving pharmacovigilance documents; reviewing safety case data and other pharmacovigilance documents for completeness and accuracy.
- Tracking, submitting and distributing of reports; trouble shoot issues if any; 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.
- To perform assist and contribute to transition related activities as per the client requirement.
- To perform TMF review and update.
- To provide relevant approval as per SOP/SWI
- To perform compliance related quality check, monthly review of Literature articles as per the guidance document
- To monitor, review and reconcile client tool/databases and identify if any discrepancy noted/noticed and troubleshoot the same.
- To request relevant access, tool, databases, Software Applications etc. as applicable
- Monitoring, tracking and reconciliation of client mailboxes and SharePoint as applicable.
- Coordinate, and contribute in the Product/Study configuration process Roles and Responsibilities: Resource management
- Coordination and Supervision - Coordinate, manage and monitor workings of various processes in the organization, including but not limited to translations, tool/system access requests, Product/Study configurations, Literature Full text approvals, Query management, case deletion approvals.
- Best Practices - Improve processes and policies in support of organizational goals. Monitor adherence to rules, regulations and procedures.
- Perform the literature QC lead activities as outlined in the Client SOP.
- Monitor submission gap reports and coordinate with Global case processing associate to complete the pending case submissions as per Client SOP.
- Production - Coordinate and monitor the work of various sections involved in production, monitor performance, and implement improvements. Provide technical support where necessary.
- Facilitate coordination and communication between support functions.
- Strategic Input - Liaison with senior management. Assist in the development of strategic plans for operational activity. Implement and manage operational plans.
- Work with HR and recruitment to ensure timely mobilization of manpower (including definition of JDs and selection of candidates).
- Planning, allocation, and reconciliation on the day-to-day activities in the project
- Ensure adherence to output targets at desired quality levels.
- Analyze MIS and take corrective action where required. Staff Management & Development
- Recruit, hire and reward high performing individuals to meet goals. Facilitate resource evaluation needs across sites.
- Ensure team members receive the necessary training to perform their job functions effectively and consistently within regulations.
- Manage both internal and external stakeholders ensuring the challenges are tackled efficiently. Process & Technology
- Understand and work to the current divisional/departmental SOPs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate.
- Lead and work with the teams to optimize processes and use of pharmacovigilance-related technology to build a more efficient organization. Encourage practical applications of new ideas.
- Formulate decisions and prioritize implementation of enhancements. Client Management
- Ensure adherence to client’s policies and procedures.
- Maintain procedures in adherence to the client’s policies.
- Ensure all the client SLAs and KPIs are met.
- Assist in audit and inspections.
- Ensure all relevant governance documents (slides and minutes) are archived in the respective folders
