Md Rashid Haider Khan
Darbhanga
Summary
A results-driven Pharmacovigilance and IT-enabled Life Sciences Consultant with 11 years of cross-functional experience in end-to-end drug safety processes, regulatory compliance, operations management, and quality assurance.
Currently working as a Periodic Report Expert Oversight at IQVIA, I specialize in enabling digital PV transformations—ensuring regulatory compliance through the smart integration of technology, data systems, and process automation.
Key Areas of Expertise:
🔹 Pharmacovigilance & Regulatory Operations – ICSR, DSUR, PSUR/PBRER, RMPs, Signal Detection, MedDRA & WHO coding, GCP, GVP, ICH
🔹 Tech-Enabled Safety Systems – Skilled in Argus, Sapphire, VigiFlow, NG-SMS, and Veeva Vault RIM Suite for global PV operations
🔹 Audit & Quality Systems – SOP writing, audit preparedness, deviation management, and CAPA implementation
🔹 Project & People Leadership – Managing cross-functional teams, mentoring junior staff, driving performance, and aligning with business goals
🔹 Digital & Data Focus – Using structured safety data and digital tools to streamline PV operations and regulatory submissions
Passionate about the intersection of technology, regulatory science, and healthcare outcomes, I am now focused on leveraging my domain knowledge to support IT-led digital transformation projects across the Life Sciences industry.
Overview
11
11
years of professional experience
5
5
Certification
Work History
Periodic Report Expert Oversight
IQVIA RDS Solution Pvt. Ltd.
01.2024 - Current
- Led global digital initiatives in periodic safety report automation and lifecycle management.
- Provides Global PSR format training, mentors new PREs, and ensures contributors understand PSR processes and quality expectations.
- Oversees compliance with PSR timelines, tracks contributions, implements process improvements, and ensures adherence to evolving regulatory requirements.
- Manages cross-functional coordination, collects regulatory and clinical data, authors and reviews high-quality pharmacovigilance content using integrated IT systems, and ensures reports are finalized for submission.
- Interfaced with health authorities during audits and ensured technology-aided root cause analysis and CAPA closure.
- Supported cross-functional global teams in digital system transitions and risk management activities.
Pharmacovigilance Scientist/Medical Writer
Tata Consultancy Services
02.2021 - 12.2023
- Created and validated regulatory documents (PBRER, DSUR, RMP) using cloud-based content platforms.
- Coordinated stakeholders across geographies through digital dashboards and data automation tools.
- Acted as a bridge between IT teams and PV domain users to enhance safety data pipelines.
- Supported surveillance strategy and signal detection using clinical databases and literature monitoring tools.
- Conducted training on regulatory writing tools and maintained compliance with QSDs and client style guides.
- Played a key role in the safety signal evaluation lifecycle, enabling data-driven decision-making through IT platforms.
Team Leader
Wipro Limited
07.2019 - 01.2021
- Oversaw a 20-member safety team, leveraging dashboards and workflow automation to manage ICSR processing.
- Implemented RCA and CAPA via IT-enabled quality review systems and regulatory audit tools.
- Conducted knowledge sharing sessions on emerging safety trends and digital compliance protocols.
- Drove performance reviews and training matrix enhancements using project management platforms.
- Supported SLA tracking through KPI-based reports integrated with internal tools.
- Manage workflows, conduct team huddles, participate in business reviews, and collaborate with cross-functional teams.
Drug Safety Associate, Serious QR/SME
Cognizant Technology Solution Pvt. Ltd.
07.2016 - 06.2019
- Review serious ICSRs for accuracy, completeness, and adherence to coding guidelines; monitor workflow to ensure compliance with SLAs and regulatory timelines.
- Perform medical coding for history, events, drugs, and procedures using standard dictionaries (MedDRA, WHO-DD); handle case intake, duplicate checks, data entry, and closure.
- Conducted training sessions, acted as a subject matter expert for clinical trial cases, and updated associates on new case processing and coding guidelines.
- Manage case allocations, follow up on queries, participate in project meetings, and provide feedback to the ICSR manager on challenges and successes.
Pharmacovigilance Technical Associate
Indian Pharmacopoeia Commission (PvPI), MOH&FW
03.2014 - 06.2016
- Collect and register ICSRs from RIMS Hospital and nearby areas in the Vigiflow database.
- Validate reports for completeness, code medical data, and perform causality assessments using WHO and Naranjo scales.
- Manage SUSAR alerts, expedited reporting, labeling, and collaborate with NCC-PvPI on ICSRs.
- Awareness & Training: Conduct sensitization programs for healthcare professionals and the public to promote pharmacovigilance awareness.
Pharmacist & Senior Warehouse Executive
M/S Guardian Life Care Pvt. LTD
02.2008 - 08.2008
- Lead the team in the absence of store manager
- Raise indent & requirements
- Coordinate between stores and head office under my supervision
- Supervise the inbound, outbound area of the warehouse
- Handled all the query regarding supply of drugs & FMCG to the various stores as well as franchise store
Medical Representative
Modi Mundi Pharma Pvt. LTD.
03.2007 - 09.2007
- Promote products to target customers, achieve sales targets, and develop local business plans to increase market share.
- Maintain visibility through regular calls, deliver tailored sales presentations, provide excellent customer service, and build long-term professional relationships.
- Organize educational events, collaborate on marketing programs, and analyze market data to refine strategies in the assigned territory.
Education
Master’s Degree - Pharmacy (Pharmacology)
Babu Banarasi Das University
Lucknow06-2013
Bachelor’s Degree - Pharmacy
Uttar Pradesh Technical University
Lucknow, India07-2011
Diploma - Pharmacy
Delhi Institute of Pharmaceutical Science And Rese
New Delhi, India07-2006
Skills
- Pharmacovigilance Systems & Automation
- Regulatory Compliance (ICH, GVP, GCP)
- Safety Report Authoring (PBRER, DSUR, RMP)
- Risk Management Planning & Signal Detection
- Quality & Audit Readiness (CAPA, SOPs)
- Clinical Safety Surveillance & Medical Review
Domain Skills
- Argus Safety, VigiFlow, Sapphire, NG-SMS, AWARE
- Veeva Vault RIM Suite, Tableau, Advanced Excel
- MedDRA, WHO-DD Coding & Causality Assessment
- Technical Writing, Content Management
- Data Visualization & Analytics Tools
- Agile & Project Management Foundations
Certification
- The Data Science of Healthcare, Medicine, and Public Health (2018)
- Artificial Intelligence for Project Managers
- Agile Product Owner Role: Foundations
- Business Analysis: Essential Tools & Techniques
- Data Visualization: Storytelling
- PMI-ACP® Preparation
Languages
English
Advanced (C1)
Hindi
Bilingual or Proficient (C2)
Timeline
Periodic Report Expert Oversight
IQVIA RDS Solution Pvt. Ltd.
01.2024 - Current
Pharmacovigilance Scientist/Medical Writer
Tata Consultancy Services
02.2021 - 12.2023
Team Leader
Wipro Limited
07.2019 - 01.2021
Drug Safety Associate, Serious QR/SME
Cognizant Technology Solution Pvt. Ltd.
07.2016 - 06.2019
Pharmacovigilance Technical Associate
Indian Pharmacopoeia Commission (PvPI), MOH&FW
03.2014 - 06.2016
Pharmacist & Senior Warehouse Executive
M/S Guardian Life Care Pvt. LTD
02.2008 - 08.2008
Medical Representative
Modi Mundi Pharma Pvt. LTD.
03.2007 - 09.2007
Master’s Degree - Pharmacy (Pharmacology)
Babu Banarasi Das University
Bachelor’s Degree - Pharmacy
Uttar Pradesh Technical University
Diploma - Pharmacy
Delhi Institute of Pharmaceutical Science And Rese
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