Pharmacovigilance Services Assoc Manager

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Assoc Manager
Qualifications:MBBS/MD
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 Song— all powered by the world’s 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? Responsible for medical review and assessment of seriousness, causality and labeling of adverse events within agreed timeframes and to a high standard of accuracy, in compliance with Client standard operating procedures and global regulatory requirements Oversee responsibilities in delivering service to the client including mobilization of resources required in delivering the service and managing their performance. Working closely with the client project lead and operations lead to manage risks, issues, and escalations and drive successful project completion with high quality.
What are we looking for? Educational and Experience Requirements: • MBBS (Medical degree), MD • Technology skills: experience with MS office, knowledge of safety database • Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred. • Good medical writing skills • Good Communication Skills • Strong English Language proficiency (Reading, Writing, Listening and Speaking) • Prior experience in managing large teams for pharmacovigilance or clinical data management functions. 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; 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 Key performance indicators • Ability to communicate effectively. • Ability to operate in a metrics driven environment. • Ability to plan, organize, and allocate optimal number of resources to deliver business results. • Ability to measure team’s performance, analyze data, and take appropriate actions. • Ability to provide effective feedback, coaching and career development opportunities for staff. • Ability to guide staff in issue resolutions and provide direction as to the proper escalation process. • Ability to manage day-to-day interaction/ coordination with client where required (system downtime, project deliverables, timelines, issue escalations, etc.). • Ability to drive projects to completion with high quality and timelines
Roles and Responsibilities: • Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs). • Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP. • Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database. • Write company causality comment and route the case to applicable workflow as per Client SOPs • Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs • Lead the training of internal and cross-functional team members. • Actively involved in case discussion with client and provide the valuable inputs to the team. • Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates. • Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs Resource management • Coordination and Supervision - Coordinate, manage and monitor workings of various processes in the organization. • 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 Staff Management & Development • Recruit, hire and reward high performing individuals to meet goals. Facilitate resource evaluation needs across sites. Process & Technology • Understand and work to the current divisional/departmental SOPs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate 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. • Contribute, review, and approve applicable documents. • Initiate SLA/KPI approvals and generate relevant reports. • Approve Literature Full text ordering requirement if needed as per the process. • Responsible for maintaining Paper envelopes