Vegesna Naga Anusha
SME and Lead: Pharmacovigilance
Summary
Pharmacovigilance professional with Masters In Pharmacology and 9+ years of experience into drug safety, case processing, compliance management, SME, social listening, safety database monitoring.
Solution Lead: LSMV and LSRA functional expertise for implementations, configurations, data migration and application support.
· Pharmacovigilance lead: Ensures effective functioning of PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
· Experience in review of ICSRs and data entry into IRT, ArisG, LSMV with good working knowledge of ICH guidelines on safety and efficacy of Regulatory guidelines, MedDRA, WHODD coding
· Compliance SPOC - Maintain QMS standard documents (including CAPA tracker)
· Social Media Analyst: Handle consumer product social media accounts (24 7 monitoring)
Overview
9
9
years of professional experience
3
3
Certifications
Work History
Associate Solution Lead (SME)
Aris Global
01.2023 - Current
- Solution Lead for safety database development and migration (DITL testing, validation, etc.) and working collaboratively with customers in safety database migration
- Conduct and Demonstrate workshop to customers/Sponsors on LifeSphere Multivigilance offerings, functionality, OOTB configurations, CIOMS/MedWatch/R2/R2 E2B reports generation
- Organize weekly Calls with 30+ CROs and Pharmaceutical companies for query resolution and enhancement requests
- Analyze and clear day to day customer queries on LSMV functionally by actioning on JIRA/SIMPL tickets raised during testing of the database
- Resolving RIT execution errors and reporting template issues. Guide implementation team to configure application as per Configuration Specification document
- Prepare and configure Correspondence templates, Distribution Rules mapping for data migration from ArisG to LSMV
- Gap analysis and user acceptance testing of application setup in Sandbox, Validation, Dev, Production environments
- End to End LSMV and ArisG functionality expert and Co-Expertise LSRA application.
- Demonstrate generating Periodic reports including but npt limited to PSUR, DSUR, PBRER, CIOML LL
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.
Education
Master of Pharmacology
Andhra University
12.2013
Bachelor Of Pharmacy
Acharya Nagarjuna University
04.2011
Skills
LSMV and ArisG
Data capture and Data Anlytics
Risk mitigation
Audit & Inspections
Configuration management support
Adverse Event Monitoring
Collaboration and innovation techniques
Microsoft office - PowerPoint, Excel, MS Word
People management
Database Management
Project Management and planning
Global Regulatory
Automation in PV
Leadership skills
MedDRA coding
Problem solving and multitasking
Basic configuration setup
Time management
Analytical and Critical Thinking
Application of AI testing solutions and technical applications
Communicative and collaborative
Data migration support
Certification
Post marketing Safety Management, DIA
Accomplishments
- Client Delight Award
- Aryabhatta Innovation Award
- Above and Beyond certificate
- 5 Spot Awards
- Evaluation of antidiabetic and anti-inflammatory activity of fatty extract of Caprus hircus milk in rats”
- Anti-Inflammatory Activity of Ethanolic Extract of Agave Cantula”
- Carboplatin-Mediated changes in the Activity Levels of Steroidogenic Marker Enzymes, Serum Hormones and Testicular Architecture in male rats”
- Clinical Review on Dereluctive Orphan Diseases”
Timeline
Associate Solution Lead (SME)
Aris Global
01.2023 - Current
Signal detection and causality assessment: UMC
10-2020
Post marketing Safety Management, DIA
07-2017
Safety Audits and Inspections, DIA
07-2017
Lead: Pharmacovigilance and Social Media Analyst
IQVIA (formerly IMS Health)
12.2014 - 10.2022
Master of Pharmacology
Andhra University
Bachelor Of Pharmacy
Acharya Nagarjuna University