ANNS RICHO T.A
Summary
Accomplished Senior Drug Safety Associate with a proven track record at Tata Consultancy Services, enhancing drug safety operations and expanding markets. Expert in pharmacovigilance, database management, and regulatory compliance. Demonstrated leadership in cross-functional collaboration and strategic planning, with a strong foundation in medical writing and quality assurance techniques.
Overview
4
4
years of professional experience
Work History
Senior Drug Safety Associate
Tata Consultancy Services
10.2023 - Current
- Ensured alignment with global pharmacovigilance guidelines through regular updates on internal procedures and protocols.
- Played an instrumental role in expanding the company''s drug safety operations to new markets, facilitating smooth integration with local regulatory requirements and ensuring seamless service delivery.
- Evaluated emerging trends in drug safety regulations, providing expert recommendations to senior management for strategic planning purposes.
- Established a strong professional network within the drug safety community, actively participating in industry conferences and events to stay abreast of emerging trends and advancements.
- Reduced risk of potential safety issues by conducting thorough literature reviews and compiling relevant information for assessment.
- Enhanced drug safety processes by implementing robust monitoring and reporting systems.
- Provided critical support during product recalls, coordinating efforts across multiple departments to ensure swift resolution of issues at hand.
- Conducted extensive pharmacovigilance audits, identifying areas for improvement and implementing corrective actions accordingly.
- Served as a key liaison between the company and external partners, fostering collaborative relationships that benefited overall drug safety operations.
- Enhanced communication channels with healthcare professionals by developing targeted educational materials on product safety information.
- Assisted in the development of risk management plans, incorporating detailed assessments of benefit-risk profiles for marketed products and investigational drugs.
Drug Safety Associate 1
Paraexcel
02.2022 - 08.2023
- Triage and register Individual Case Safety Reports (ICSRs) in safety databases, manage duplicates, and ensure compliance with global regulatory requirements
- Conduct regulatory intelligence research, interpret regulations, and support reporting rules using Argus.
- Maintain knowledge of adverse event safety profiles, reference safety information, and international drug safety regulations.
- Demonstrated expertise in project management, leadership, and team mentorship.
- Proven ability to manage workload, prioritize effectively, and build strong relationships with coworkers, managers, and clients.
- Detail-oriented with excellent organizational and time management skills.
Drug Safety Associate
IQVIA
02.2021 - 11.2021
- Responsible for triaging and registering Individual Case Safety Reports (ICSRs) in safety databases, ensuring compliance with global regulatory timelines.
- Conducted duplicate searches, managed duplicate cases, and maintained knowledge of adverse event safety profiles and international safety regulations.
- Supported regulatory intelligence research, monitoring updates, and interpreting relevant guidelines.
- Assisted in case processing, narrative writing, and follow-up activities. Demonstrated strong organizational skills, attention to detail, and effective time management.
- Collaborated with cross-functional teams and contributed to safety data analysis. Developed expertise in using Argus and other safety databases for reporting and case management.
Education
Doctor of Pharmacy -
KLE COLLEGE OF PHARMACY
Hubli, India05.2020
Skills
- Adverse event reporting
- Quality Assurance Techniques
- Database management proficiency
- Pharmaceutical industry knowledge
- Pharmacovigilance expertise
- Medical writing aptitude
- Drug safety regulations
Timeline
Senior Drug Safety Associate
Tata Consultancy Services
10.2023 - Current
Drug Safety Associate 1
Paraexcel
02.2022 - 08.2023
Drug Safety Associate
IQVIA
02.2021 - 11.2021
Doctor of Pharmacy -
KLE COLLEGE OF PHARMACY
Similar Profiles
Vrunda ChindhadeVrunda Chindhade
HR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services LimitedHR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services Limited
Sreya BasuSreya Basu
Procare Analyst at Tata Steel(Tata Consultancy Services)Procare Analyst at Tata Steel(Tata Consultancy Services)
Arun VArun V
Program Manager at Tata consultancy services | Financial Ombudsman ServicesProgram Manager at Tata consultancy services | Financial Ombudsman Services