Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:Any Graduation
Years of Experience:7 to 11 years
About Accenture
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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 Client Project Lead and Service Delivery Lead to manage risks, issues, and escalations and drive successful project completion with high Quality for aggregate reporting team. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? Educational requirement: B.Pharm / M.Pharm / PhD / BDS /BHMS /BAMS/ Masters in Life Sciences. Work experience requirement: 6+ years of experience in drug safety / Development or closely related areas of responsibility.
Roles and Responsibilities: • Responsible for the deliverables by team members. • Tracking of stages and milestones of aggregate reports as per predefined schedule for the team. • Follow escalation process as per Client process for any misses by team members. • Ensure training and mentoring of new aggregate reporting associates and documentation of the same. • Address any quality related issues and implementation of quality improvement initiatives for the team. • Best Practices - Improve processes and policies in support of organizational goals. Monitor adherence to rules, regulations and procedures. • Provide delivery updates in monthly operation steering committee meeting. • Ensure retention of team members. • Ensure project compliance according to Client SOPs. • Timely generate RCA-CAPA for any SLA/ SOP deviation. • Strategic Input - Liaison with senior management. Assist in the development of strategic plans for operational activity. Implement and manage operational plans.