Haleem.com
Haleem, not a dish
I am J Haleem.
– Life Science Product Manager
Experienced in team building, mentoring, and leadership in geographically distributed culturally diverse environment. Strong domain acumen (Life Sciences – Bio Pharma, Medical Devices) to establish credibility with business stakeholders. Worked with product development team and business team to identify and position market offerings across life sciences value chain – R&D, Clinical Data Management, Pharmacovigilance, Commercial, Manufacturing, Regulatory and IT.
Product Management
Analytics
Audit and Inspection
Gen AI
My Passion
PV
• Managed and collaborated with an agile team comprising of PV product teams, vendors, offshore team and cross-functional teams (Clinical Data Management, Commercial, Quality, IT & Analytics).
• Conducted interviews with PV business stakeholders to maintain their pain points, user stories, roadmap, backlogs, business values and timelines.
• Proactively communicated the realistic and holistic product KPIs with the Senior Leadership Team during Quarterly business review, audits, system upgrades, change management and, CAPA.
• Collaborated with internal/external technical teams to shape the IT Service Management.
• Integrated and retired applications with innovative and high-impact solutions to reduce the Total Cost of Ownership and to increase ROI.
• Solicited Request for proposals, conducted Conference Room Pilots with stakeholders, negotiated pricing with vendors and approved SOWs and SOPs.
• Reduced infrastructure expenses by 35% by lifting and shifting systems from in-house to the vendor’s SaaS.
• I oversaw the robotic and manual delivery of 10,000 reports (both expedited and periodic) each year, effectively reducing operational cost while ensuring high quality deliverables.
• Worked with IQVIA to build an AI-based Social Media Intelligence for post-market surveillance
CDM
• Administration and helpdesk support of Oracle Life Science Applications (Oracle Clinical, Thesaurus Management System, and Oracle RDC), LIMS and, Source Data Verification for 500+ users globally for Clinical Systems (Clinical Data Management, Medical Coding & Dictionary Management, EDC and Informatica Data Warehouse applications).
• Troubleshooting, system testing, system administration, maintenance and, monitoring interfaces.
• Wrote validation/derivation procedures (edit checks), entire study startup database development and randomization using Oracle Clinical 4.0.7. Created data extract views, developing reports using Integrated review.
• I was in-charge of writing and validating Oracle Clinical 4.5 user acceptance test (UAT) cases for “Oracle Corporation”. These UAT includes DVGs, DCI and DCM layout generation and creating a model study at the Global Library
Volleyball
Windsor Athletic Club, Princeton, NJ
Education and Experiences
Master in Business Administration (MBA) – 2014
From – Annamalai University
Management and information systems.
Bachelor of Science in Computer Science – 1993
From – Bharathidasan University
Computer science and information systems.
High School Leaving Certificate – 1990
From – Hameediah Higher Secondary School
Associate Director – 2020-2024
From – Merck & Co
Forecasting, IT budgeting, and compliance for a portfolio of GxP applications.
Assistant Director – 2019-2020
From – Bayer Healthcare
Liaison between Clinical Drug Safety Pharmacovigilance and other part of the organization.
Safety Data Manager – 2015-2019
From – Otsuka Pharmaceuticals
Identifying business intelligence solutions, validating, implementing, training, and supporting PV systems.