ANSON MATHEW JOSEPH
Aldie, VA
Summary
Pharmacovigilance Specialist with extensive experience in safety practices and regulatory compliance. Proven track record in enhancing drug safety monitoring through analytical and problem-solving skills. Former Assistant Manager – Audit and Compliance, recognized for high productivity and effective task execution. Expertise in risk management and QMS, with strong communication skills for successful collaboration during audits.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Associate, Quality Assurance
Arco Lab Private Limited (A Strides Enterprise)
Bangalore, Karnataka
04.2024 - 06.2025
- Conducted tactical review of Quality Assurance processes to analyze SOP effectiveness and identify gaps.
- Coordinated reviews of agreements, including MSA, TQA, SDEA, and SOW.
- Maintained compliance systems to enhance customer satisfaction levels.
- Delivered induction training for new employees on Quality Assurance practices.
- Managed periodic reviews of Quality Assurance functions to drive continuous improvement.
- Ensured timely disposition of Quality Management System records for accuracy and accessibility.
- Prepared and reviewed Standard Operating Procedures, work instructions, policies and manuals for clarity and compliance.
- Maintained internal audit plan, ensuring completion aligned with established standards.
- Implemented an end-to-end vendor management module in the TrackWise system.
Associate, Quality Assurance
Arco Lab Private Limited (A Strides Enterprise)
Bangalore, Karnataka
04.2023 - 03.2024
- Prepared for internal, external, and customer inspections to ensure audit readiness.
- Reviewed compliance of corrective and preventive actions (CAPA) and Root Cause Investigations (RCI) for timely audit closure.
- Facilitated internal audits, vendor audits, licensing partner audits, and overall audit management activities.
- Participated in investigation and approval processes for Root Cause Investigation records.
- Delivered training on relevant subjects to enhance team knowledge.
- Evaluated change control, deviation, investigations related to GxP systems, CAPA, and effectiveness check records.
- Conducted tactical reviews of the Medical Affairs process to identify gaps and implement corrective measures.
- Maintained effective compliance systems and processes to ensure high levels of customer satisfaction.
Associate-Medical Affairs (Pharmacovigilance- Quality Assurance)
Arco Lab Private Limited (A Strides Enterprise)
Bangalore, Karnataka
06.2021 - 04.2023
- Facilitated vendor qualifications and initiated change control for project enhancements.
- Ensured regulatory compliance and maintained accurate Medical Affairs staff training records.
- Verified the accuracy of data entry for triaged and processed ICSR records, including MedDRA coding.
- Conducted quality reviews of closed ICSRs, and provided feedback.
- Coordinated with teams to gather information for aggregate and signal report preparation.
- Reviewed compliance of electronic and manual submission of ICSRs to authorities.
- Validated safety data transfer with partners following SOPs.
- Monitored compliance for the initiation of PV activities for new product approvals.
Senior Drug Safety Associate
Bioclinica India Pvt. Ltd.
Mysore, Karnataka
11.2018 - 06.2021
- Oversaw email intake, duplicate checks, and ICSR registration in the safety database.
- Maintained logs of ICSR source documents and communications for case tracking.
- Evaluated validity of cases, completing thorough triage processes.
- Executed data entry for individual case safety reports into safety database.
- Reviewed adverse event information to assess case validity and urgency.
- Processed incoming cases to adhere to strict timelines.
- Coded medical histories, events, drugs, and laboratory tests using appropriate dictionaries.
- Authored medically relevant safety narratives while verifying accuracy of entered data.
- Reviewed data entered in the safety database for completeness and accuracy concerning source documents, as per applicable SOPs, work instructions, and client guidelines.
Internship
Cosmopolitan Hospital Pvt. Ltd.
Trivandrum, Kerala
07.2017 - 05.2018
- Completed a one-year internship at a 550-bedded multi-specialty hospital in Kerala, India (Cosmopolitan Hospital Pvt.). Ltd.) in General Medicine, Gynecology, Pediatrics, Pulmonology, and General Surgery.
- Acquired clinical experience through a six-month clerkship in a 550-bedded multi-specialty hospital in Kerala, India, under the Pulmonology, Gynecology, General Medicine, and Pediatrics departments.
- Participated in a one-month pharmacy rotation at Multispecialty Hospital Pharmacy in Kerala, India.
Education
Doctor of Pharmacy (Pharm D) - Pharmacy
Sree Krishna College of Pharmacy And Research Centre
Trivandrum08-2018
Skills
- Pharmacovigilance and regulatory compliance
- Quality management systems
- Audit and documentation management
- Corrective action implementation
- Process improvement strategies
- Training delivery and mentoring
- Performance monitoring and evaluation
- Vendor management and relations
- Deviation Management and Root cause analysis
- GDPR compliance (ISMS and PIMS)
References
- Dr. Gopal Muralidharan, Function Head of Medical Affairs, gopal.muralidharan@arcolab.com, +91-9108434505, Arcolab Private Limited, a Strides Enterprise
- Ms. Archana Kamath, Senior Director, Quality and Partnerships, archana.kamath@arcolab.com, +91-9686602777, Arcolab Private Limited, a Strides Enterprise
Projects
PHARM D PROJECT: A Prospective Study on Assessment of Severity of Depression and Impact of Patient Counseling on Knowledge, Attitude and Practice among Patients with COPD in a Multispecialty Tertiary Care Hospital
SOFT SKILLS
- Good leadership and guidance qualities.
- Collaboration with others with mutual respect, trust, and credibility, as well as frequent and honest communication.
- Strong written and verbal communication skills.
- Passionate about taking responsibility.
Certification
- Registered pharmacist, Kerala State Pharmacy Council
- Certified QMS auditor
Timeline
Senior Associate, Quality Assurance
Arco Lab Private Limited (A Strides Enterprise)
04.2024 - 06.2025
Associate, Quality Assurance
Arco Lab Private Limited (A Strides Enterprise)
04.2023 - 03.2024
Associate-Medical Affairs (Pharmacovigilance- Quality Assurance)
Arco Lab Private Limited (A Strides Enterprise)
06.2021 - 04.2023
Senior Drug Safety Associate
Bioclinica India Pvt. Ltd.
11.2018 - 06.2021
Internship
Cosmopolitan Hospital Pvt. Ltd.
07.2017 - 05.2018
Doctor of Pharmacy (Pharm D) - Pharmacy
Sree Krishna College of Pharmacy And Research Centre
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