Chandilkumari kanthakumar
Bengaluru
Summary
To obtain a challenging position as a Drug Safety Associate in Pharmacovigilance, where I can apply my scientific knowledge and analytical skills to monitor, assess, and report adverse drug reactions, ensuring patient safety and regulatory compliance. I aim to contribute to a dynamic team dedicated to improving drug safety standards and protecting public health
Overview
5
5
years of professional experience
Work History
Drug Safety Associate (PV)
Accenture solutions pvt Ltd
07.2023 - Current
- Job description:
- Key Responsibilities:
- Data Review and Quality Assurance:
- Reviewing Individual Case Safety Reports (ICSRs) for accuracy, completeness, and adherence to regulatory guidelines.
- Ensuring the quality and consistency of pharmacovigilance data, including adverse event reports and safety data.
- Performing quality checks on safety reports (e.g., PSURs, DSURs) before submission to regulatory authorities.
- Identifying and escalating any data quality issues or discrepancies.
- Process Improvement:
- Identifying areas for improvement in pharmacovigilance processes and procedures.
- Contributing to the development and implementation of new or revised pharmacovigilance SOPs.
- Supporting the development and maintenance of the Risk Management Plan (RMP).
- Data Collection and Entry:
- Gathering and entering adverse event information from various sources, in post-marketing surveillance.
- Maintaining and updating safety databases with accurate and timely information.
- Case Processing and Assessment:
- Reviewing and evaluating adverse event reports (AERs) and individual case safety reports (ICSRs).
- Following up on cases to obtain complete information and ensure timely reporting.
- Coding adverse events using standard terminologies like MedDRA.
- Collaboration and Communication:
- Collaborating with other departments, such as clinical research, medical affairs, and regulatory affairs.
- Communicating with healthcare professionals and patients regarding adverse events.
- Other Responsibilities:
- Supporting the administration of pharmacovigilance meetings.
- Assisting with audits and inspections.
- Participating in the development and implementation of pharmacovigilance procedures.
- Working software
- With experience in Oracle Argus Safety, a pharmacovigilance software, well-positioned to contribute to the pharmaceutical and biotechnology industries, managing adverse event data and ensuring regulatory compliance.
Hospital pharmacist
Urban Primary Health Care centre
09.2020 - 02.2023
- Key Responsibilities: Hospital pharmacist
- Medication Dispensing and Management:
- Accurately dispense medications as prescribed by healthcare professionals.
- Review prescriptions for accuracy, appropriateness, and potential interactions.
- Manage medication storage, inventory, and distribution within the hospital.
- Patient Care and Counseling:
- Provide patients with information about their medications, including dosage, administration, potential side effects, and storage.
- Address patient concerns and questions regarding medications.
- Other Duties:
- May be involved in medication reconciliation, adverse drug event reporting, and medication budget planning.
Education
B. Pharmacy -
St. John collage of Pharmacy
01.2011
Intermediate (BI. P.C) - undefined
Padmavathi Joiner Collage
01.2006
S.S.C - undefined
Unique High School
01.2004
Skills
- Computer knowledge of PGDCA, Excel, Power point, Word and Etc…
Language Known
English: Read, Write, Speak
Hindi: Read, Write, Speak
Telugu: Read, Write, Speak
Tamil: Speak
Timeline
Drug Safety Associate (PV)
Accenture solutions pvt Ltd
07.2023 - Current
Hospital pharmacist
Urban Primary Health Care centre
09.2020 - 02.2023
Intermediate (BI. P.C) - undefined
Padmavathi Joiner Collage
S.S.C - undefined
Unique High School
B. Pharmacy -
St. John collage of Pharmacy
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