Harshakumar Shetty
Summary
As a business compliance partner focused on ethics and compliance, my experience leading compliance operations across India and 67+ countries at Bharat Serums & Vaccines (BSV), where I currently serve as General Manager & Head of Compliance (promoted from Senior Manager in 2020 and DGM in 2022), has equipped me with a deep understanding of establishing and driving EBI Program. My previous role as Country Ethics & Compliance Officer at GlaxoSmithKline (GSK) Cambodia (EY Seconded) further honed my ability to ensure adherence to global compliance standards within a multinational environment. With a proven track record in ethics and compliance, forensic investigations, and internal audits within both the consumer and pharmaceutical industries, I am adept at fostering an ethical culture that enables fast ethical decision-making and accountability, while strategically aligning with business objectives. My experience includes providing ethics and compliance advice and support to business for a broad spectrum of marketing activities and brands. Recognized for driving impactful initiatives, as evidenced by the Business Impact Award (BSV, 2022) for innovation and simplification, the Global Employee Recognition (Pharma, 2018) for compliance excellence, and multiple EY Accelerator Awards (2015, 2016, 2018) for expanding the life sciences practice. Currently, I am enrolled in the Leadership in AI program at the Indian School of Business in Hyderabad.
Results-driven compliance leader with a proven track record in governance frameworks, risk assessment, and data analytics. Achieved 100% compliance training completion globally, driving ethical culture and stakeholder engagement.
Overview
19
19
years of professional experience
4
4
years of post-secondary education
Work History
General Manager & Head of Compliance
Bharat Serums and Vaccines Limited
10.2020 - Current
- Led India's Compliance (EBI) Program (policy, training, monitoring, third-party vetting), achieving a 100 % compliance training completion across the globe
- Provided strategic ethics and compliance counsel to country leadership
- Advised stakeholders across medico-marketing, commercial, and digital marketing on compliance matters.
- Drove ethical culture initiatives based on survey, compliance week resulting in 98% compliance in proposal submissions
- Established the Global Ethics & Compliance Committee, enhancing governance.
- Reported compliance matters to the Compliance Committee and ensured local regulatory compliance (UCPMP compliance, DPDP Act, Potential Conflict of Interest matters etc.)
- Oversaw Third Parties due diligence Program
- Conducted investigations (including whistle-blower cases), implementing corrective actions.
- Implemented predictive monitoring and data analytics to identify and mitigate compliance risks (Example credit note analyses, marketing compliance to compliance standards)
- Generated data-driven insights on compliance trends to inform action plans.
- Drove and monitored execution of Compliance enhancement/remedial plans.
- Represented company in external industry forums (Data Privacy, Data Integrity, ABAC).
- Collaborated with region specific experts for developing country specific policies in Southeast Asia.
Manager
EY
01.2015 - 09.2020
- During my tenure at EY, I was seconded as Country Ethics and Compliance Officer at GSK Cambodia, leading the compliance function.
- Implemented third-party oversight and supported risk committees in tracking mitigation plans.
- Streamlined operations through process reviews and fostered a speak-up culture.
- Led investigations, conducted ABAC training, and advised on complex decisions.
- Managed global audits while promoting ethical practices.
Senior Consultant
EY
01.2013 - 12.2015
- As a forensic investigator at EY, I handled whistleblower investigations for a global pharmaceutical company, focusing on healthcare compliance, supply chain, and sales.
- I specialize in probing false claims by sales employees for conferences and CME events, conducting field visits to validate invoices.
- I also investigated a pharma distributor for bribing government HCPs, product mixing, double billing, and financial fraud, playing a key role in leading the case.
- Additionally, I led a data theft investigation for an automobile company and participated in an FCPA probe for a construction firm, uncovering bribes and invoice manipulation.
- Analyzed market trends to identify opportunities for client growth and improvement.
- Mentored junior staff in best practices for consulting methodologies and client management.
- Established strong working relationships with both internal teams as well as external vendors and clients.
Manager
Dr. Reddy's Laboratories
12.2011 - 12.2012
- Manager at DRL India Limited, I was part of the Risk Management and SOX Compliance team and responsible for conducting risk management assignments worldwide.
Deputy Manager
Dr. Reddy's Laboratories
12.2010 - 12.2011
- As part of the risk management and SOX compliance team at Dr. Reddy's Laboratories, I conducted financial and operational audits across the U.S., Mexico, and India, assessing controls per the SOX Act and recommending improvements.
- Key contributions: Streamlined manual controls with cross-functional teams.
- Ensured comprehensive Risk Control Matrix with business units.
- Developed a unified Risk Control Matrix (RCM) for best practices.
- Drove control automation initiatives.
- Led audit teams, overseeing assignments, reporting, and training.
- Prepared quarterly Audit Committee reports on internal audit effectiveness, open audit findings, and fraud investigations.
Assistant Manager
Deloitte India
01.2007 - 10.2010
- As a member of the Control Assurance Department (CAD) at Hindustan Unilever Limited, my responsibilities include conducting end-to-end process reviews at various locations, including factories, depots, third-party manufacturing locations, distributor locations, and commercial operations.
Education
Certification - Leadership in Artificial Intelligence
ISB Hyderabad
01.2025 - 08.2025
Certification - Diploma in IFRS
ACCA
06.2011 - 12.2011
Chartered Accountant - Audit
The Institute of Chartered Accountants of India
Cost Accountancy -
Institute of Cost Accountants of India
Bachelor's Degree - Commerce
R A Podar College of Commerce And Economic
Mumbai 04.1997 - 03.2000
Skills
- Compliance management
- Risk assessment
- Governance frameworks
- Data analytics
- Policy writing
- Stakeholder engagement
- Regulatory knowledge
- Third-party oversight
- Investigative techniques
- Team leadership
- Ethical decision making
- Effective communication
- Problem solving
- Cultural awareness
- Training facilitation
- Motivation
- Supervision and training
- Networking
- Marketing
- Data review
- Budget forecasts
Languages
English
Upper Intermediate
B2
Timeline
Certification - Leadership in Artificial Intelligence
ISB Hyderabad
01.2025 - 08.2025
General Manager & Head of Compliance
Bharat Serums and Vaccines Limited
10.2020 - Current
Manager
EY
01.2015 - 09.2020
Senior Consultant
EY
01.2013 - 12.2015
Manager
Dr. Reddy's Laboratories
12.2011 - 12.2012
Certification - Diploma in IFRS
ACCA
06.2011 - 12.2011
Deputy Manager
Dr. Reddy's Laboratories
12.2010 - 12.2011
Assistant Manager
Deloitte India
01.2007 - 10.2010
Bachelor's Degree - Commerce
R A Podar College of Commerce And Economic
04.1997 - 03.2000
Chartered Accountant - Audit
The Institute of Chartered Accountants of India
Cost Accountancy -
Institute of Cost Accountants of India