Summary
Overview
Work History
Education
Skills
Websites
Certifications Training
Disclaimer
Timeline
Generic
Abhishek Jha

Abhishek Jha

Pune

Summary

Dedicated and experienced pharmacovigilance professional with strong background in drug safety and regulatory compliance. Proven track record of leading successful pharmacovigilance delivery projects and ensuring adherence to industry standards and guidelines. Skilled in managing teams fostering client relationship and driving process improvements to optimize delivery operations.

Overview

18
18
years of professional experience

Work History

Delivery Partner

Tata Consultancy Services
Pune
09.2023 - Current
  • Implemented customer service strategies to promote increased levels of customer satisfaction and loyalty.
  • Ensured team compliance with policies, procedures and regulations related to customer service.
  • Managed multiple complex projects with competing timelines, budgets and resources.
  • Created a comprehensive framework for customer success initiatives.
  • Conducted research to identify customer needs, preferences and trends.
  • Organized focus groups to collect feedback from customers on new products or services.
  • Built relationships with key stakeholders across all departments within the organization.
  • Provided support during internal and external audits when requested by management.
  • Developed relationships with customers through proactive communication, follow-up, and problem resolution.

Delivery Manager

Tata Consultancy Services
Pune
08.2014 - 07.2020

Managed ~250 FTE team of PV professionals delivering Global ICSR activities for a large Pharma company including Case Intake, Case processing, medical review, Quality review, EMA Submission, Study reconciliation, GPS MAP, PV Partnering support, Regulatory reporting services and other ancillary ICSR support activities.

  • Responsible for leveraging TCS G&T approach to create the right value for the customer and their business. Manage P&L, deliver growth & profitability, deliver projects & services on schedule and budget. Drive operational metrics, implement policies & governance and supervisory administration of people managers.
  • Contributed to the development of Global functional strategy and objectives at customer organization by active participation in customer management meetings
  • Ensured team is audit/inspection ready, supported all customer site inspections, participated in CAPA development, rollout, and effectiveness monitoring as appropriate
  • Successfully completed many critical and sensitive projects involving huge case volumes by implementing innovative ideas and process changes
  • Ensuring seamless service delivery of the entire PV project by organizing and coordinating all external and Internal activities
  • Coordinating all resource, attrition, and recruitment management for PV projects within the engagement
  • Drive and endorse the implementation of process improvement initiatives
  • Build effective, high performing Operations teams through influence, integration, motivation and optimizing team performance
  • Embedding the customer values into the team culture, promoting team spirit and the client/TCS partnership

Assistant Manager

Tata Consultancy Services
08.2012 - 08.2014
  • Overall accountability of day-to-day case processing activities including Service Level Agreement monitoring and focusing on compliance. Accountable for proactive workload management within teams and across the function to ensure that internal and regulatory timelines are met.
  • Collaborating with other Team Leaders, Group Leaders, Project Manager and Client Resource Management Group to discuss workload and proposed solutions to fluctuating workload as needed.
  • Proactively identifying trends in compliance and propose solutions to case processing and resourcing issues. Identifying and implementing continuous improvement activities.

Assistant Manager

iGATE PATNI
09.2010 - 08.2012
  • Review data against source document and perform individual case safety report processing on day-to-day basis
  • Accountable for proactive workload management within team and led a team of case processing individuals.

Senior Drug Safety Associate

Accenture Services Pvt. Ltd
05.2007 - 09.2010
  • Review data against the source documents (case report forms, handwritten notes, CIOMS I form, MedWatch)
  • Perform MedDRA coding of AE verbatim and medical history terms, Source Data Verification and handling Independent Projects, and study team.
  • Clinical Data Management, primarily role involved Case Report Form (CRF) Indexer, Staging Table Monitor, Database Auditor and processing of CRFs.

Lecturer of Biochemistry

T. John College
07.2006 - 04.2007

Education

Master of Science - Biochemistry

T. John College
Bangalore
01.2006

Bachelor of Science - Biotechnology

City College
Bangalore
01.2004

Skills

  • Project Management
  • Business Consultation
  • Strategic Thinking
  • Result Oriented
  • Problem Solving
  • Business Intelligence
  • Quick Learner
  • People Management
  • Leadership
  • Data Analysis
  • Lean Six Sigma
  • G&T Advisor
  • Agile Ninja Coach
  • Design Thinking
  • Effective problem solving
  • Negotiation skill

Certifications Training

  • Growth & Transformation Practitioner
  • Agile Ninja Coach
  • Lean Six Sigma Black Belt
  • Design Thinking for Growth and Transformation Consultants Certification
  • Business analysis - Life sciences
  • Professional Scrum Master I
  • Delivery Management Certificate
  • Lean Six Sigma Green Belt Certification

Disclaimer

I hereby declare that the above-mentioned information is true to my best knowledge.

Timeline

Delivery Partner

Tata Consultancy Services
09.2023 - Current

Delivery Manager

Tata Consultancy Services
08.2014 - 07.2020

Assistant Manager

Tata Consultancy Services
08.2012 - 08.2014

Assistant Manager

iGATE PATNI
09.2010 - 08.2012

Senior Drug Safety Associate

Accenture Services Pvt. Ltd
05.2007 - 09.2010

Lecturer of Biochemistry

T. John College
07.2006 - 04.2007

Master of Science - Biochemistry

T. John College

Bachelor of Science - Biotechnology

City College
Abhishek Jha