Amarjeeth رجا

Director, Service Operations في Quintiles Research Private Limited

• الهند - بنغالورو
• أشغل هذه الوظيفة منذ يوليو 2012

Role:
 Manage and lead a large team of 550+ pharmacovigilance professionals in Tier 1 client account.
 Drive strategy, business planning and execute delivery for the Pharmacovigilance enterprise and ensure customer focus, customer awareness and increase in market share. Deliver efficiency by developing and monitoring performance metrics and measures using latest technology tools.
 Ensure continued business by efficient client engagement by focusing on productivity, delivery and quality of all services committed to the client.
 Successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for advancement of all goals and objectives
 Has a broad expertise related to understanding the principles and application of quality and regulatory compliance related to GPVP regulated activities
 Possess a strong aptitude for facilitating group or project team endeavors, and building team unity
 Advanced ability to effectively communicate and influence the outcomes of the decision making process
 Displays highly developed organizational leadership qualities
 Ability to design and develop advanced QA systems and programs
 Keenly understands Global PV regulatory environment and emerging global PV standards
 Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
 Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to GPVP, and quality systems and management
 Formulate department goals and ensures linkage to individual goals
 Display highly effective coaching abilities as well as a successful track record of developing junior staff
 Conduct presentations on quality issues, initiatives and projects at cross functional meetings
 Develop and maintain a high quality and efficient adverse event intake, review and reporting structure for investigational and marketed products, while adhering to governing SOPs, work instructions and FDA/ICH guidelines and regulations.
 Ensures appropriate systems are in place for monitoring global procedures and practices
 Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements
 Development, implementation, and oversight of quality activities in support of GPVP activities conducted or monitored by Client. These activities include qualification and monitoring of GPVP Service Providers, monitoring internal GPVP quality systems, supporting regulatory inspections, performing duties required of an internal Quality Assurance Unit, and building cross-functional agreements on strategic quality initiatives
 Assist with the establishment and maintenance of relevant SOPs and work instructions to support efficient process and procedures. Participate in continuous improvement of all department processes and procedures
 Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements
 Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests
 Establish and maintain appropriate forecasting tools for reporting forecasted utilization.

Safety Business lead في Oracle India Pvt Limited

• الهند - دلهي
• يناير 2009 إلى يوليو 2012

Role: Solution Architect and Business Lead for Oracle’s Argus Safety Suite of products-

Involved in all phases of project execution for 7+ Safety Suite Implementations which included 3 Tier 1 Clients and 3 Tier 2 pharma clients
Projects spanning over Anglo European and Japanese Regions with region specific implementations with regard to FDA, EMA and Japanese health authority.
Preparing the RFPs and SOWs with respect to products suited and tailored for client’s requirements
Pricing, budgeting and planning of agreements with negotiate approach to arrive at client level acceptable solution.
Provide and guide clients with solutions to data warehousing applications for reporting and safety signal detection activities.
Help client in planning and performing application testing and validation activities, providing validation package of IQs, OQs and PQs.

Implementation Experience
 Conducted and Participated in activities focused on defining and documenting the business requirements via series of workshops for 2 Clients of Tier 1 (US and Europe) 1 Client of Tier 2 (US).
 Led and successfully completed an analysis for a client that was migrating to Argus Safety Suite. Identified key issues and prepared OQ scripts with dry run of the application with minimal impact to customer base. Supported the testing and validation efforts to enable a successfully tested and validated safety and reporting system in a defined customer specific SOP in 1 Client of Tier 1
 Participated in installation, infrastructure planning and environmental maintenance activities in 1 Client of Tier 1 and 1 client of Tier 2.
 Lead for Periodics and Ad-hoc Reports: Performed fit-gap analysis and lead the workshop for aggregate as well as periodic reporting. Custom designed more than 50 reports as per client’s requirements. PSUR/ ASR and PADER/IND submission listings were conceived, configured and implemented as per the client’s reporting practices in 2 Tier 1 clients. Document the custom and standard reports requirements and design. Develop, design, build, and successfully validate custom and standard reports.
Deliverables included: Report High-Level Design and Report Low-Level Design. Report High-Level Requirements Document and the Fit Gap Analysis Document.

 Part of team in the development, design, build, and successful validation the required integration points. Prepared OQ and dry-run was conducted at Client environment.
Deliverables included: Safety data transfer document.

 Safety Signalling Business Lead : Functional Lead in Phase 1 and 2 Projects, Conducted Signal Detection Business process re-engineering in 2 of Tier 1 Clients and Oracle certified partners. Conducted business workshops for Perceptive signaling application for a renowned client in US with its signal detection team based out of Dublin, Ireland. Technical support/ Issue Manger on all Perceptive/ Signal Analytics related issues.
 Reconciled, Consolidated and Recreated the Expedited Reporting Rule Configuration of a Tier I client. Project was focused around FDA, Health Canada, EMEA and EU Member State guidelines -
o New Reporting rule creation scope involved - License Partner, WHO Drug Reporting, Third party Agents, DSOs and Cross Study Reporting
o Reconciliation and modification of existing reporting rules was done in line to regulatory requirements.
Argus Safety Suite Training
 Provide Business Trainings as in “train-the-trainer” approach.
 Business training imparted on PV practices and business aspects of application to new hires

Safety Expert في Novartis Health Care Pvt. Ltd.

• غير ذلك
• يناير 2008 إلى ديسمبر 2008

 Prepared the team for FDA audit, MHRA and EMA audits.
 Responsible for pharmacovigilance processes and global safety data processing.
 Building and managing all safety related activities of major class of therapeutic agents.

Assistant Manager في Lambda Therapeutic Research Ltd. Ahmedabad

• غير ذلك
• مايو 2007 إلى ديسمبر 2007

• Phase 1 and 2a clinical trials (New Drug Development):
Involvement in planning and preparation of synopsis/ protocol for new molecules
Prepared synopsis for POC studies in COPD and Asthma, Evaluated new drugs in Osteoporosis, Prostate cancer, Rheumatoid arthritis, Aneurysm/Atherosclerosis, Psoriasis, Multiple Sclerosis and IBS.
• Phase 3a and 4 clinical trials
Planning (Protocol and CRF), Conduct (Clinical trial operations) and Reporting (Clinical trial report), Prepared protocol for antiepileptic, antiplatelet, antipsychotic and antihypertensive, Regulatory document reviews, Bioequivalence report justification, Non-clinical and clinical overviews, Medical data package, Prescribing information and patient information leaflets for different countries and Investigators brochure for India
• Other activities
Preparation of SOP, Evaluation of in-licensing products for decision on collaboration, Evaluation of new fixed drug combination and NDDS of established drugs as new products, guiding new appointees for the above functions
• Familiarity with
ICH, FDA, CPMP and CDSCO guidance.

Medical officer في Lotus Labs, Bangalore

• غير ذلك
• يوليو 2004 إلى مارس 2007