Vegesna Naga Anusha

Lead: Pharmacovigilance and Social Media Analyst

IQVIA (formerly IMS Health)

12.2014 - 10.2022

Perform initial evaluation of reported adverse events (serious and non-serious) from all sources, perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in safety database – ArisG/LSMV based on individual case histories, correspondence with affiliates in complex projects
Oversee status and end to end Management of adverse events arising from various sources including Market research, Patient support programs, Customer engagement program, literature and prepare Individual Case safety Reports (ICSR)
Manage, collaborate, release and deliver PV projects with cross-functional teams of 70+ members based in Bangalore, Colombo, Spain, Manila with multilingual data and complete case processing with good interpersonal skills and communicational skills with om time project delivery as per consumer needs
Support the global teams to drive the delivery of Pharmacovigilance case management activities with high quality and compliance
Set-up, implement, organize (including documentation) and lead safety management teams for signal detection
Co-author and finalize aggregate reports, including but not limited to PBRERs/PSURs, line listings with aggregate project Lead
Develop and communicate detailed project scope/product specific Safety Management Plans (e.g Communication plan, quality plan, data migration, quality documents)
Detail oriented and Ontology, Machine Learning related processes in PV projects and decision making in AE Tracker functionalities
Perform Root cause Analysis (RCAs), Write and provides recommendations for Corrective and Preventative Actions (CAPAs)
Design, prepare, maintain performance metrics and provide performance feedback and growth and encourage teamwork with good communication skills
Optimize and integrate risk management in Case processing projects (IRT and ArisG) which includes Receipt, record and follow-up of adverse events and any safety information associated with the customer requirements and issues
Resource Management - Sharing of Metrics, leave planning estimation, Regular updates to team
Provide heads-up on project related / resource related risks as and when identified PV effort estimation and regular monitoring, develop and monitor KPIs
Signal detection by looking at the adverse reaction data for patterns that suggest new safety information
Communicate and ensure compliance of SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process flow
Participate in scheduled or ad hoc audits/inspections and ensure inspection readiness
Collaborate with onshore stakeholders weekly with scope and vision to work on continuous improvement, change management, improve business processes
Execute company social media accounts management (24/7 monitoring)
Ownership of Client's social media channels including execution of activations from concept to post-implementation analysis
Analyze the long-term needs of company's social media strategy and offer quarterly reports to the management and executive teams that outline any necessary changes to the digital marketing plan
Plan, Monitor and Optimize content for the website and social networking channels such as Facebook, Twitter, Instagram, YouTube, LinkedIn, Edit and post content, videos, on online sites.