SUNAKSHA KUMARI
Richmond,BC
Summary
More than four years of experience in pharmacovigilance including triage, data entry and validation and quality review of Individual Case Safety Reports (ICSRs). Experienced in handling ICSRs of various case types (Spontaneous, Clinical studies and Solicited programs, and literature cases). Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation). Trained and mentored PV scientists in various activities of case processing. Trained in preparation of periodic safety reports (PSRs) for pharmaceutical products in accordance with client/international conventions including Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Safety Statements and Semi- Annual Safety Reports (SASRs) and checking of International Non-proprietary Names (INNs) for inclusion in a PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs).
Overview
6
6
years of professional experience
Work History
Drug Safety Associate II/ Pharmacovigilance Analyst
PAREXEL International Services India Private Limited
04.2022 - 12.2022
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labelling doc and SOPs, and Global drug safety regulations, CAPA (corrective and preventive actions) and deviations
- Assist in development of project specific safety procedures, workflows and templates
- Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Attend internal, drug safety, CAPA and project specific training sessions
- Preparation for, participation in, and follow up on audits and inspections
- Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
- Acting as a Subject Matter Expert for validation team
- Monitoring of incoming reports from various sources via mailboxes, EudraVigilance, literature searches etc
- Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
- Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
- Perform a check on overall medical cohesiveness and consistency of the document
- Compares and analyses data provided by the affiliate with the data available on client application
- Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
- Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)/supporting documents
- Review ancillary documentation accompanying ICSRs and identifying the relevant information for processing and capture on the client safety database
- Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
- Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider”
- Ensure that the reports are scheduled for submissions, as required
- Performs quality checks/validation checks to ensure accuracy of information captured, and that expectedness, causality and seriousness are correctly assessed
- Supports compliance activities including late case investigation of ICSRs to various
- Health Authorities and business Partners to determine the assignable cause for lateness, collection of lateness documentation including corrective actions, where applicable
- Responsible for mentoring of drug safety associate-I to ensure confident coding of
- ICSRs including literature cases
- Acting as a Subject Matter Expert for validation team
- Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
- Drug Safety Reporting
- Quality control of case reports, line listings, and tabulations
- Performing submissions of cases and aggregate reports within stipulated timelines through client safety database, Eudravigilance, Common European Submission Portal (CESP) and other modes of submissions (e.g Courier, email, etc.), as applicable and to provide submissions ready documents to Named Contract Person (NCP) in a timely manner
- Collect and review metrics for measuring reporting compliance Unblinding of SUSARs, as required
- Collect and review metrics for measuring reporting compliance
- Literature search and review: Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests
- Review of the literature searches received via email from the client and request the full text articles and entering the valid cases into the client database.
Drug Safety Associate
PAREXEL International Services India Private Limited
07.2020 - 03.2022
- Provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs)
- Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions, performing distribution of ICSRs to Affiliates/Partners/CROs and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable
- Responsible for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable
- Narrative writing
Pharmacovigilance Scientist
PAREXEL International Services India Private Limited
09.2018 - 06.2020
- Under training for maintaining awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Processing of ICSR (individual case safety reports)
- THERAPEUTIC AREA EXPERTISE: Endocrinology, Oncology, Neurology, Consumer healthcare products
- Gathered and evaluated quality assurance data to identify issues and improve process efficiency.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Assitant Pharmacist
Grover Medicos
01.2017 - 08.2018
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Carried out day-day-day duties accurately and efficiently.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Worked flexible hours; night, weekend, and holiday shifts.
- Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
- Check prescription orders from nursing home, review narcotic reconciliation, dispense and verify medication in compliance with state federal regulations.
- Served customers and followed outlined steps of service.
- Review and process electronic prescriptions for accuracy quality.
- Consult with physicians and/or nursing staff via telephone regarding orders, interaction and patient reactions to medications.
- Manage drug inventory assist with drug file maintenance.
- Assist with quality improvement initiatives.
Assistant dentist
Arora Dental Clinic Pathankot
07.2016 - 12.2016
- Examining patients, taking and interpreting radiographs and diagnostics tests to determine type and extent of dental diseases, disabilities or dysfunctions
- Strong familiarity with X-Ray machines, forceps, brush and scalpels and other equipment used in dental treatment.
- Educated patients and families about dental issues and proper oral care to prevent dental decay and disease.
- Efficiently completed dental procedures for restorative work.
- Interpreted X-rays to make accurate diagnoses and decisions about treatments.
- Extracted teeth, performed root canals and filled cavities with dedication to pain management.
- Advised patients on appropriate treatment for pain following procedures by giving specific home care instructions.
- Diagnosed and treated infections, mouth ulcers and other problems with oral mucosa.
- Interviewed patients, reviewed health history information and performed checkups to diagnose oral issues and diseases.
- Communicated one-on-one with patients during consultative appointments to explain treatment plan and educate on upcoming procedures.
Education
Bachelor of Dental Surgery -
Baba Farid University of Health Sciences, Government Dental College
2016
12th Standard - undefined
Punjab School Education Board
2010
10th Standard -
Punjab School Education Board
Pathankot, Punjab, India2008
Skills
- Computer skills with experience in MS Word, Excel, PowerPoint, Office, and Outlook, Microsoft Office (Microsoft Word, Microsoft Excel, Power Point), AWARE, SCEPTRE And ARISG Software Proficiency, Chemdraw, Sceptre, QUOSA Software Proficiency
- Data retrieval from various databases such as Google scholar, PubMed, Science Direct, Research gate
- Compliance Training, Personnel Training
- Root Cause Analysis
- QC Reporting
- Regulations Compliance
- Database Maintenance
- Regulatory Requirements
- Risk Management
- Medical Terminology
- Quality Assurance Maintenance
- Signal Generators
- Standard Operating Procedure
- Data Entry
Timeline
Drug Safety Associate II/ Pharmacovigilance Analyst
PAREXEL International Services India Private Limited
04.2022 - 12.2022
Drug Safety Associate
PAREXEL International Services India Private Limited
07.2020 - 03.2022
Pharmacovigilance Scientist
PAREXEL International Services India Private Limited
09.2018 - 06.2020
Assitant Pharmacist
Grover Medicos
01.2017 - 08.2018
Assistant dentist
Arora Dental Clinic Pathankot
07.2016 - 12.2016
Bachelor of Dental Surgery -
Baba Farid University of Health Sciences, Government Dental College
12th Standard - undefined
Punjab School Education Board
10th Standard -
Punjab School Education Board
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