Bittu Thomas
Pharmacovigilance Professional
Cambridge,ON
Summary
Highly skilled Pharmacovigilance Specialist with extensive experience in adverse event management and global regulatory compliance. Committed to ensuring patient safety through meticulous attention to detail and effective risk management. Seeking a leadership position in a dynamic pharmacovigilance team, leveraging diverse skills and unwavering dedication to drive excellence in drug safety and regulatory affairs.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
Work History
Operations Specialist
IQVIA
Kochi, Kerala, India
09.2019 - 12.2021
- Achieved 20% process improvement in study timelines by implementing streamlined workflows for case processing on clinical trials, patient support programs, and
- Ensured timely and accurate reporting of safety data, enhancing regulatory compliance and data
- Identified root causes of errors through comprehensive analysis, enabling effective error mitigation and process
- Improved team performance by implementing solutions aligned with GCP and ICH guidelines, resulting in a quality increase above
- Ensured compliance with regulations by providing product training to over 20 staff members and updating training
- Proficient in safety databases like Aris G, Argus, MedDRA events, and ICD Disease codes for regulatory compliance and clinical databases like Medidata RAVE and
- Generated actionable reports to support critical decision-making by management.
Senior Drug Safety Associate
Bioclinica Safety & Regulatory Services
Mysore, Karnataka, India
06.2017 - 09.2019
- End-to-End ICSR Case Processing: Proficiently manage the complete processing of Individual Case Safety Reports (ICSRs) encompassing serious, non-serious, study, and spontaneous cases. Skilled in data entry, labeling, approval numbers, manual coding, and narrative writing to ensure accurate and high-quality
- Expertise in Literature Triaging: Demonstrated capability in efficiently conducting literature triaging and processing to identify and incorporate relevant safety information into case
- Subject Matter Expert in Safety and Quality Review: Act as a subject matter expert in Literature, Spontaneous cases processing, and quality review, ensuring adherence to regulatory requirements and company
- Training, CAPA Management, and Customer Communication: Proficiently handled training and mentoring of team members, CAPA management, and effective communication with local safety officers and customers to resolve queries and clarify information as per project requirements
Drug Safety Associate
IQVIA Inc
, India
02.2016 - 05.2017
- Leveraged SCEPTRE and Argus databases and MedDRA (Medical Terminology) to accurately enter and process alphanumeric data for more than eight daily cases in the life sciences department.
- Reviewed ancillary documentation to identify information for processing and electronic capture to comply with GCP and ICH guidelines.
- Communicated with internal and external contacts as part of customer relationship management to resolve issues and complaints related to case processing.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
Clinical Pharmacist
KIMS Hospital
Trivandrum, Kerala, India
02.2015 - 02.2016
- Conducted clinical auditing twice for the
- Provided patient assistance, drug information for inquiries, and patient
- Conducted various pharmacology and pharmaceutical studies as part of clinical research in the
- Trained more than eight pharmacists and other medical
- Performed Quality Control Data Verification and drafted risk profiles.
Education
Health Care Administration And Service Management - Health Care Administration
01.2022 - 04.2023
Doctor of Pharmacy - Pharmaceutical Medicine
09.2011 - 01.2015
Bachelor of Science - B. Pharm
09.2006 - 12.2010
Skills
- Clerical Support
- Processing Orders
- Prescription Filling
- Receiving Incoming Supplies
- Secure Storage of Medications
- Cash Register Operation
- Corrective Actions
- Payment Processing
- Pharmacist Assistance
- Addressing Customer Inquiries
Timeline
Conestoga College Institute of Technology And Advanced Learning - Health Care Administration And Service Management, Health Care Administration
01.2022 - 04.2023
Operations Specialist - IQVIA
09.2019 - 12.2021
Senior Drug Safety Associate - Bioclinica Safety & Regulatory Services
06.2017 - 09.2019
Drug Safety Associate - IQVIA Inc
02.2016 - 05.2017
Clinical Pharmacist - KIMS Hospital
02.2015 - 02.2016
Dr.MGR Medical University - Doctor of Pharmacy, Pharmaceutical Medicine
09.2011 - 01.2015
Mahatma Gandhi University - Bachelor of Science, B. Pharm
09.2006 - 12.2010
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