Abhishek Pandey
Manager Pharmacovigilance
Noida
Summary
Management professional Pharmacovigilance ~Proposal Management~ Operations Management ~ Transitions ~Training & Solutions ~ Business Development
An accomplished Pharmacovigilance professional with 10+ years of rich experience with well-known organizations across the verticals of Proposal Management, Project Management, Operations, Business development, proposal management, Solutions, Transitions and stakeholder management. Key domain areas include US and European Healthcare, Project Solutioning and Transition, Operations delivery, Proposal Management and Business development, Customer relationship management (CRM), Regulatory requirements, Market research and management, Analytics, Pharmacovigilance, Post Market surveillance (PMS)
Overview
11
11
years of professional experience
Work History
Manager (Pharmacovigilance)
Pharmalex India Pvt. Ltd.
04.2021 - Current
- Responsible to take part in client / stakeholder meetings and discussions and lead transition activities
- Understanding project goals, deadlines, priorities and associated risks
- Establishing a project transition plan – overview of tasks and timelines needed to execute the project
- Working closely with relevant support functions to set up the processes within specified deadlines
- Setting up periodic meetings between stakeholders / client and responsible to provide progress update
- Tracking all relevant set-up activities prior Go-live of a project and ensuring availability of systems for the operation delivery team
- Responsible for handing over the operation team established delivery system (SOPs, WI/WPs, QMS system, IT Infrastructures, Database, tracking tools etc.)
- Keeping an oversight for a set period of time (Hypercare period) from Go live till the team achieves a steady state
- Analyzing and summarizing the results of the transition.
Assistant Manager – Pharmacovigilance
Pharmalex India Pvt. Ltd.
01.2019 - 03.2021
- Pharmacovigilance operations for a leading Europe based drug manufacturer
- Project span – 5+ FTEs
- To perform quality check of ICSRs and causality assessment
- To perform the case processing of ICSRs
- To initiate electronic reporting of ADR cases
- Ensure compliance with internal standards and external regulations
- SME and Global service coordinator for PV intelligence reports
- Responsible for screening various regulatory authority websites for identifying and analyzing the Pharmacovigilance (PV) requirements, covering pre- and post-marketing PV pharmaceutical laws and regulations, electronic submissions, clinical trial applications and pre- and post-marketing PV activities
- Communicating of potential PV insights to Country PV Representatives/Local Service Coordinators PV Intelligence
- SME – Training modules and SOP writing
- Preparing training module as per the current industry practices and in accordance with GVP modules
- Preparing SOPs and guidelines as per the requirement
- Domain expert and work with internal training team to design the training and learning modules, SOP and guideline creation
- Planning & executions of Internal ramps & transitions.
Group Leader (Assistant manager)
Wipro Ltd. – Healthcare & Life Sciences
10.2013 - 12.2018
- Responsible for achieving all project SLA’s, attrition control, people management, Quality delivery
- Process excellence
- Solutioning and Planning & executions of Internal ramps & project transitions
- Proposal Management
- Addressing RFIs
- Preparation of initial Proposals
- Participation if providing responses for RFPs
- Participating in Bid defenses
- Medical Information System setup and Management support
- Providing support in initial set up of phone systems and MI databases
- Creation of project specific SOPs and working practices
- Global service coordinator for PV intelligence reports
- Responsible for screening various regulatory authority websites for identifying and analyzing the Pharmacovigilance (PV) requirements, covering pre- and post-marketing PV pharmaceutical laws and regulations, electronic submissions, clinical trial applications and pre- and post-marketing PV activities
- Communicating of potential PV insights to Country PV Representatives/Local Service Coordinators PV Intelligence
- SME – Training modules and SOP writing
- Preparing training module as per the current industry practices and in accordance with GVP modules
- Preparing SOPs and guidelines as per the requirement
- Domain expert and work with internal training team to design the training and learning modules, SOP and guideline creation.
Education
Bachelor of Pharmacy -
Indira Gandhi Institute of Pharmaceutical Sciences (Bhubaneswar, Odisha)
Intermediate - undefined
BEM School, ISC Board Belpahar, Odisha
Matriculation - undefined
BEM School, ICSE Board Belpahar, Odisha
Skills
Operations delivery
providing business solution and lead Transition for new projects
Training modules designing and SOP writing
Creation of initial Proposal and participating in RFP/RFIs and Bid defenses
regulatory screening and analyzing the Pharmacovigilance (PV) requirements, covering pre- and post-marketing PV pharmaceutical laws and regulations
Client & Business lead Reviews
Bottom Quartile Management (BQM)
Monthly Business Review (MBR)
Team Responsibilities (Performance, Grievance Handling etc)
Training, Backfill & Hiring
Attrition Management
Calculation & Maintenance of CPMs (Critical Process Metrics) for eg on time percentage, turn-around time (TAT), average handling time (AHT), quality
Business Administration
Operations Management
Business Development
Performance Management
Strategic Planning
Customer Relationship Management (CRM)
Project Management
Cross-Functional Teamwork
Staff Management
Staff Training and Development
Business Planning
Performance Evaluations
Verbal and written communication
Complex Problem-Solving
Team Leadership
Time Management
Budget Control
Key Performance Indicators
Process Improvement
Revenue Forecasting
Project Planning
Multitasking Abilities
Training and Development
Positive Attitude
Teamwork and Collaboration
Interpersonal Communication
Business Analysis and Reporting
Workforce Management
Professional Snapshot
- Pharmalex India Pvt. Ltd., Manager (Pharmacovigilance), 01/2019, Present
- Wipro Ltd. – Healthcare & Life Sciences, Group Leader (Assistant manager), 10/2013, 12/2018
Domain Expertise
- Operation management
- Project Transition and business solution
- Process excellence
- Training module design
- Proposal Management and Business development
- Medical Information System Setup and support
- Regulatory Intelligence
- Customer relationship management (CRM)
- Regulatory requirements
- Market research and management
- Analytics
- Pharmacovigilance
- Post Market surveillance (PMS)
- Medical Devices and ICD Coding
Roles And Responsibilities
- Project Transition Lead: Planning & executions of project transitions
- Operations Delivery : Responsible for achieving all project SLA’s, attrition control, people management, Quality delivery, TNI, BQM(Bottom quartile Management), and AVM(Agent variation Management)
- Business planning, forecasting, P & L, YoY revenue growth & projections, including revenue per hour, Revenue per FTE, operating margins etc.
- Drive PIP(Performance Improvement Plans) for continual improvement in process efficiencies
- Manage client and stakeholders’ expectations, review decks, leading monthly/quarterly/ & internal reviews
- Fostering a healthy and competitive environment, incentive plans/approach notes, approvals, ROI etc.
- Driving innovations across projects towards improvements in people & systems by contributing as an SME in various automations projects such as Robotics & analytics
- Domain expert and work with internal training team to design the training and learning modules, SOP and guideline creation
- Proposal management : Responsible to identify clients need and create initial proposal for Global and Local PV services
- Providing responses for RFIs, participating in RFPs and Bid defenses
- Integrated PV MI (Medical Information) system set up and support
- Regulatory Intelligence : Responsible for screening various regulatory authority websites for identifying and analyzing the Pharmacovigilance (PV) requirements, covering pre- and post-marketing PV pharmaceutical laws and regulations, electronic submissions, clinical trial applications and pre- and post-marketing PV activities
- Active participation in workshops for project improvement and efficient delivery, I.e. Lean, Six sigma, GB projects. Etc.
- Participations in internal & external audits including ISO, MQA, client etc.
- Conducting internal reviews for reporting line
- Annual appraisal reviews for team members
Quality Projects
- Lean Project on “Client Mentorship” as a team member
- Lean Project on “Quality Improvement Plan” as a team member
- Continuous Improvement Project on “Quality Remediation Plan” as a project leader
Personal Information
Date of Birth: 08/15/89
Training
- Wipro Lean Certified
- Wipro Train the trainer certified
- Workshop on Six sigma
- Voice & Accent training
Timeline
Manager (Pharmacovigilance)
Pharmalex India Pvt. Ltd.
04.2021 - Current
Assistant Manager – Pharmacovigilance
Pharmalex India Pvt. Ltd.
01.2019 - 03.2021
Group Leader (Assistant manager)
Wipro Ltd. – Healthcare & Life Sciences
10.2013 - 12.2018
Bachelor of Pharmacy -
Indira Gandhi Institute of Pharmaceutical Sciences (Bhubaneswar, Odisha)
Intermediate - undefined
BEM School, ISC Board Belpahar, Odisha
Matriculation - undefined
BEM School, ICSE Board Belpahar, Odisha