Honey Ninama
Pharmacovigilance Associate
Ratlam
Summary
Highly skilled, agile and Pharmacovigilance Associate with over 6 years of comprehensive experience in the pharmacovigilance field. Demonstrated ability to analyze complex data, ensure timely and accurate submission of safety reports.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Associate
Apcer Lifesciences
02.2023 - Current
- Manage intake and triage of Individual Case Safety Reports (ICSRs) within the safety database, ensuring adherence to pharmacovigilance and regulatory requirements.
- Perform comprehensive ICSR case processing and quality review activities to maintain high standards of data accuracy and compliance.
- Perform case merging, deletion, and duplicate check activities to ensure database integrity and consistency.
- Handle invalid case management, and perform necessary follow-up and reconciliation activities.
- Contribute to the PADER preparation.
- Address queries promptly.
- Execute data correction and maintenance activities to enhance the quality and reliability of safety data.
- Support internal and external audit activities by ensuring process compliance and documentation readiness.
- Mentor and guide new team members on safety database workflows, case processing, and quality standards.
- Collaborate with management and support in additional pharmacovigilance activities, as needed.
Pharmacovigilance Associate
Arcolab (Strides Entity)
09.2022 - 02.2023
- Experienced in ICSR case processing on Argus Database and worked as a Peer reviewer.
- Support in timely submission of expedited and non-expedited cases.
- Worked in the Aggregate team and was writing PADER.
Drug Safety Associate I
Qinecsa
12.2021 - 08.2022
- Worked as peer reviewer and evaluated AE case information to determine required action.
- As a medical coder, responsible for coding all the medical history, events, drugs, procedures, indications, and laboratory tests, according to the appropriate dictionary (MedDRA, Company product dictionary, WHO-DD). Performs listedness assessment.
Drug Safety Associate
Tata Consultancy Services
05.2020 - 12.2021
- Experienced in ICSR case processing in safety database.
- Entered extracted information into global database for serious and non-serious AE/ADR case reports, ensuring comprehensive tracking of safety data.
Education
Bachelor's - Pharmacy
Royal Institute of Management And Advanced Studies
Ratlam06-2019
Skills
- ICSR management
- Case processing
- Quality review
- Hands-on Argus database
- MedDRA knowledge
- Adaptability
- Quick Learning capability
- Communication skills
Accomplishments
- Star Performer award, APCER and TCS
- Academic excellence awards, B. Pharmacy
Timeline
Pharmacovigilance Associate
Apcer Lifesciences
02.2023 - Current
Pharmacovigilance Associate
Arcolab (Strides Entity)
09.2022 - 02.2023
Drug Safety Associate I
Qinecsa
12.2021 - 08.2022
Drug Safety Associate
Tata Consultancy Services
05.2020 - 12.2021
Bachelor's - Pharmacy
Royal Institute of Management And Advanced Studies