Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Safety Writing

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 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 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 Responsible for leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team [SMART] reports) and project management of Safety Surveillance team (SST) meeting within the, agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented ilil Quality documents as applicable.

What are we looking for? Educational and Experience Requirements o Minimum Education requirement: Degree in Life Sciences or Healthcare degree o Work experience requirements: Minimum of 3 years of Aggregate report experience with 3 years of signal management process experience o Working knowledge of Good Clinical Data Management Practices, GVP (Good Pharmacovigilance Practices), ICH Good Clinical Practices o Experience with MS Office products o Ability to work independently under tight time constraints o Good interpersonal skills and the ability to, operate effectively in an international environment

• 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. 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. 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
• 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 Literature review: On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. o Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the SMART meetings. o Complete the Literature Search Alert Tracker once GSO response received
• SMART Meeting
• SST Meetings
• Perform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the SMART meetings and/or weekly team meeting