Namrata Singh
Woolloongabba,Australia
Summary
Highly accomplished and results-oriented Pharmacovigilance (PV) professional with over 12 years of experience, including more than 5 years in people management. Expertise includes overseeing end-to-end PV operations, ensuring compliance with global regulatory obligations, and driving continuous process improvements. Proven track record in managing case processing, monitoring Service Level Agreements (SLAs), and implementing Corrective and Preventive Actions (CAPA) based on Root Cause Analysis (RCA). Strong foundation in ICH-GCP guidelines and hands-on experience with data entry for Individual Case Safety Reports (ICSRs), query management, and investigator follow-up enhance the ability to uphold clinical data integrity and patient safety.
Before transitioning to PV, I gained 5 years of hospital as a clinical assistance (3 years as a part-time and 2 years as a full time) with general hospital management experience.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Associate Manager, Regulatory Reporting
IQVIA
05.2023 - 03.2025
- Tracked and ensured accurate and timely reporting of cases to global regulatory authorities, maintaining compliance with all relevant legislation.
- Managed compliance and deviation processes, and supported the implementation and monitoring of CAPA following RCA.
- Contributed to global initiatives, including change management and Subject Matter Expert (SME) committees.
Associate Manager, Safety Operations
IQVIA
06.2021 - 04.2023
- Supervised and mentored Safety Operations staff, managing their professional development and performance appraisals.
- Collaborated with managers to address operational challenges, optimize project workflows, and manage peak workloads to meet departmental targets.
- Ensured project deliverables met quality and productivity goals, and successfully managed reconciliation activities, achieving 100% compliance.
- Led stakeholder discussions and ensured timely project completion in line with SOPs and ICH/FDA regulations.
- Effectively able to manage people's issues.
Team Lead & Workflow Manager
Tata Consultancy Services (TCS)
01.2019 - 06.2021
- Oversaw all day-to-day case processing activities, ensuring strict adherence to SLAs and compliance with SOPs.
- Managed and optimised team resources and workflows to improve efficiency and productivity.
- Led RCA and implemented CAPA, continuously monitoring compliance.
- Fostered a positive team environment through regular communication and performance feedback, and ensured all documentation was audit-ready.
ICSR Technical Trainer & Mentor
Tata Consultancy Services (TCS)
03.2014 - 12.2018
- Developed and delivered in-person, online, and onsite training sessions to enhance subject matter comprehension.
- Conducted pre- and post-training assessments to evaluate trainee skill development.
- Collaborated with leadership to identify and assess training requirements.
- Monitored and evaluated program effectiveness through systematic recording of training activities.
Pharmacovigilance Scientist
Tata Consultancy Services (TCS)
07.2012 - 02.2014
- Analyzed aggregate data from clinical trials and post marketed drugs to evaluate adverse event frequency for investigational drugs and post marketed drugs.
- Reviewed adverse event reports for accuracy and compliance with regulations.
- Managed timelines for pharmacovigilance deliverables aligned with project milestones.
- Collaborated with internal stakeholders on individual patient case statuses and safety inquiries.
Clinical assistance
Unnati Hospital
01.2007 - 06.2012
- Performing clinical evaluation and assessment of OPD patient, case taking, indoor patient medical management, assisted in post-operative patient management and care, post-operative notes writing and records keeping, billing issues handling, general hospital administration, post-operative follow-up review, patient query resolving, counselings of patients and advising patients on medical and life management.
Education
M.D. - Homoeopathic Pharmacy
Foster Development’s Homoeopathic Medical College
Maharashtra University Of Health Science01.2010
Bachelor of Science - Bachelor in Homoeopathic Medicine & Surgery
Smt. Chandaben M Patel Homoeopathic Medical College
Maharashtra University Of Health Science01.2006
Skills
- Regulatory compliance in pharmacovigilance
- Clinical management expertise
- Proficient in ARISg and Argus software
- Operational management
- Project coordination skills
- Effective time management
- Employee performance review
- Workflow optimization strategies
- Implementation of best clinical practices
- Documentation management
- Adverse event reporting and tracking
- Quality management
- Leadership skills
- Effective communication
- MS Excel Suite
- Reconciliation activities
- Data Analysis
- Audit and Inspection readiness
Accomplishments
- Documented and addressed root cause/s for delayed or missed reporting which led to improvement to reporting compliance.
- Achieved 100% compliance with excellent quality by completing safety reporting reconciliation activities with accuracy and efficiency.
- Supervised team of 40+ staff members.
Certification
Lean Practitioner Training Certification (2022)
Languages
English
Full Professional
Hindi
Native or Bilingual
Timeline
Associate Manager, Regulatory Reporting
IQVIA
05.2023 - 03.2025
Associate Manager, Safety Operations
IQVIA
06.2021 - 04.2023
Team Lead & Workflow Manager
Tata Consultancy Services (TCS)
01.2019 - 06.2021
ICSR Technical Trainer & Mentor
Tata Consultancy Services (TCS)
03.2014 - 12.2018
Pharmacovigilance Scientist
Tata Consultancy Services (TCS)
07.2012 - 02.2014
Clinical assistance
Unnati Hospital
01.2007 - 06.2012
M.D. - Homoeopathic Pharmacy
Foster Development’s Homoeopathic Medical College
Bachelor of Science - Bachelor in Homoeopathic Medicine & Surgery
Smt. Chandaben M Patel Homoeopathic Medical College
Core Competencies
ICH-GCP guidelines, Global PV Regulations, Case Processing, Regulatory Reporting, SLA & Deviation Management, RCA & CAPA Implementation, Reconciliation Activities, People Management, Team Leadership, Workflow Optimisation (Lean Practitioner), Compliance Monitoring & Audits, Stakeholder Management, Medical management, Patient query resolving and counselling, General Hospital management, ARISg (v 6.3, 6.6, 7.4), Argus (7, 8.1, 8.2, 8.2.3.1, 8.4), MS Office Suite
Therapeutic Experience
- 8.5 years: Oncology & Rheumatology (e.g., arthritis)
- 7.0 years: Immunology (e.g., autoimmune disease) & Respiratory (e.g., asthma)
- 1.5 years: Infectious Disease (e.g., COVID-19)
In these roles, I was responsible for overseeing timely case movement, ensuring data quality, and performing follow-ups in accordance with client SOPs and regulatory guidelines.
Education Certifications
- M.D. Homoeopathic Pharmacy, Foster Development’s Homoeopathic Medical College, India, 2010-01-01
- B.H.M.S, Smt. Chandaben M Patel Homoeopathic Medical College, India, 2006-01-01
- Lean Practitioner Training Certification, 2022-01-01
Awards Honours
- Impact Award: Received Bronze and Silver Awards for maintaining quality and providing innovative process improvement ideas.
- Client Appreciation: Recognised for excellent case processing quality and for leading a team to successfully complete challenging tasks.
- Multiple Awards: Received 'Star Performer Award,' 'Group Performance Award,' 'Performance Linked Reward,' and 'Service and Commitment Award.'
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