Pharmacovigilance Services Specialist

Roles & Responsibilities
• Coordinate, manage, and monitor various processes in the organization, including translations, tool/system access requests, product/study configurations, literature full text approvals, query management, and case deletion approvals
• Improve processes and policies to support organizational goals and monitor adherence to regulations and procedures
• Perform literature QC lead activities as outlined in the Client SOP
• Monitor submission gap reports and coordinate with the global case processing associate to complete pending case submissions
• Provide technical support where necessary and implement improvements
• Facilitate coordination and communication between support functions
• Assist in the development of strategic plans for operational activity and manage operational plans
• Work with HR and recruitment to ensure timely mobilization of manpower, including defining job descriptions and selecting candidates
• Plan, allocate, and reconcile daily project activities, ensuring adherence to output targets and quality levels
• Analyze MIS and take corrective actions when needed
• Ensure team members receive necessary training to perform their functions effectively and consistently within regulations
• Manage internal and external stakeholders to tackle challenges efficiently

Qualification
• Graduate in Life Sciences (Bachelor of Ayurvedic Medicine and Surgery, or Bachelor/Master Degree in Life Sciences)

Experience
• 7 to 11 years of experience in Pharmacovigilance operations, drug safety, and regulatory requirements
• Experience in managing large teams with a strong focus on client management and service delivery
• Good understanding of patient/drug safety, individual case safety reports (ICSRs), and global regulatory requirements

Vacancies
• Various positions available

Skills
• Strong interpersonal, leadership, and communication skills
• Ability to work independently and under tight time constraints
• Creative problem-solving and lateral thinking skills
• Strong analytical ability and attention to detail
• High energy and drive to lead large teams in dynamic business environments

About The Company
Accenture is a global professional services company that combines unmatched experience and specialized skills across over 40 industries. Accenture offers 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