Anjalidevi P
Drug Safety Associate
Kurnool
Summary
Experienced professional seeking a challenging role in a dynamic, forward-thinking organization with significant opportunities for growth. Leveraging my skills and education, I am dedicated to driving sustained progress and development for the organization and myself.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
3
3
Languages
Work History
Senior Process Associate
Tata Consultancy Services
Bangalore
04.2021 - 03.2024
- Processed a wide range of safety reports, including clinical trial, spontaneous, NIP/MAP, Non-Interventional Study, vaccine cases and special situation cases, ensuring timely and accurate documentation.
- Conducted thorough triage of incoming reports, validating completeness, duplicate checks, legibility, and ensuring data accuracy and compliance with regulatory standards.
- Utilized MedDRA, Company Product Dictionary, and WHO-DD for precise coding of medical history, adverse events, drugs/procedures, indications, and laboratory tests.
- Wrote medically relevant safety narratives, ensuring that all data fields were accurately completed, while maintaining high standards of clinical and regulatory compliance.
- Assessed expectedness, causality, and seriousness criteria for reported adverse events, ensuring accurate classification and adherence to pharmacovigilance guidelines.
- Ensured compliance with internal timelines and regulatory requirements for adverse event reporting, including ICH E2E, FDA, and EMA guidelines.
- Managed follow-up requests and handled query resolution in a timely manner to gather additional safety information, ensuring the completeness of case files.
- Maintained process-specific trackers to manage workflow, ensuring efficient tracking and timely processing of adverse event reports.
- Identified and escalated literature and medical device safety cases to appropriate teams for further review and action.
- Participated in internal training sessions and project-specific workshops, continuously enhancing knowledge of pharmacovigilance processes and regulations.
- Completed all training assignments on the internal Learning Management System (LMS), meeting deadlines and ensuring proficiency in pharmacovigilance practices.
- Assisted in case distribution and lot pulling, optimizing allocation of cases to all the teams.
- Conducted quality reviews of cases, ensuring data integrity and compliance with pharmacovigilance standards.
- Actively contributed to DIP case processing, providing leadership support in team activities and case assessments when needed.
- Led team operations and ensured the continuity of activities in the absence of the team leader, taking on leadership responsibilities to maintain smooth team functioning.
Education
Master of Science - Pharmacology
JNTU Anantapur
Anantapur, India 09.2018 - 07.2021
Bachelor of Science - Pharmacy
CES College of Pharmacy
Kurnool, India 05.2014 - 08.2018
Skills
- Safety databases: Aris G and Sapphire
- Proficient in MedDRA and WHODD Standards
- Data analysis tools: MS Excel
- Good interpersonal skills
- Expertise in correlating patient medical history, laboratory data
- Appropriateness in selection of drugs
Accomplishments
- Received Pragathi and Saksham scheme Scholarship for 4 years in B. Pharmacy.
- Received Star of the month award in TCS.
Disclaimer
I do hereby declare that the particulars of information and facts stated herein above are true, correct, and complete to the best of my knowledge and belief.
Timeline
Senior Process Associate
Tata Consultancy Services
04.2021 - 03.2024
Master of Science - Pharmacology
JNTU Anantapur
09.2018 - 07.2021
Bachelor of Science - Pharmacy
CES College of Pharmacy
05.2014 - 08.2018
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