Argus 70 and 80
A Anisha
Pharmacist
Bengaluru,KA
Summary
PROFILE SUMMARY:
6.5 years of experience in Drug and Device Pharmacovigilance (ICSR Case Processing, Quality Check, Triage and Case Initiation/Book-In, Process case files, Data reassessing, Reconciliations, Responding to Health Authority inquiries, Schedule expedited and periodic regulatory reports based on local and international reporting regulations) .
Overview
5
5
years of professional experience
4
4
years of post-secondary education
2
2
Certificates
Work History
Patient Safety Specialist
Alcon
Bangalore, KA
05.2022 - Current
- Job Purpose:
- Role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products, and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives. This role may be required to work in shifts.
- Major Accountabilities:Case Processing:
- Process case files according to Standard Operating Procedures (SOP).
- Work with affiliate offices to ensure required dataset has been received/requested.
- Re-assess data, ensure accurate product selection and assign required event code(s) in system.
- Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).
- Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
- Launch required quality investigation records.
- Schedule expedited and periodic regulatory reports based on local and international reporting regulations.
- Perform and receive quality feedback on case management and coding.
- Adherence to all corporate compliance guidelines & corporate programs .
- Maintains working knowledge of following:
- Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials)
- Eye anatomy
- Common diseases
- Ophthalmic evaluation procedures
- Eye terminology and abbreviations
- Safety database(s) and reporting tools
- Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs)
- Provide support in reconciliation activities and audit as required.
- Evaluate and escalate potential safety issues to management.
- Key Performance Indicators:
- Meets internal and external quality standards
- Review and close files within prescribed timelines
- Creates high quality regulatory reports for submission on or before assigned due dates.
Drug Safety Specialist
Fidelity Health Services
Mumbai, Maharastra
02.2020 - 10.2020
- Responsibilities: Quality Reviewer
- Performing Quality Control Check on all type of cases to ensure information reported to client is
- Complete and accurate.
- Raising queries if there is any discrepancy found in case which is entered in data base and solving them in timely manner.
- To prepare reports on error rate periodically to identify major area of error fields for reports received via workflow and come up with solution to overcome these errors in that
- Particular fields.
- To be updated with new updates in case processing guidelines from client and taking
- Sessions on updates.
- Data entry as and when required in case of spike in case volumes.
Junior Data Analyst
Cognizant technology Solutions
Mumbai, Maharastra
04.2018 - 01.2020
- Responsibilities: Book-In
- Check for source documents in Intake folder
- Redact any inappropriate information as applicable.
- Perform duplicate search.
- Check if document will process as initial or Follow-up.
- Responsibilities: Triage
- Check if case is Valid/Invalid or Non-case/No New information (NNI) report.
- Checking for seriousness and listedness of cases.
- Differentiating case as periodic or expedited.
- Causality assessment of cases.
Senior Drug Safety Associate
Bioclinica Safety and Regulatory Solutions (Synowledge Pv Service India Pvt. Ltd),
Mysore, KA
10.2015 - 03.2018
- Experience And Job Role:
- Responsible for processing Adverse Event cases to ARIS-g database provided by client.
- Responsible for case intake, duplicate check and registration.
- Maintain log of source documents and other communications.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Process all incoming cases in order to meet timelines.
- Assist in signal generation and safety analysis activities.
- Review of literature articles to identify case safety reports.
- Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.
- Responsible for entering:
- (a) Source document details
- (b) Cross reference
- (c) Case/Patient information
- (d) Past medical history
- (e) Reporter information
- (f) Event information
- (g) Product information of suspects and concomitant drugs, their dosing schedule, indication
- Responsible for coding of all medical events, drugs /procedures/implements according to appropriate dictionary (for e.g. MedDRA, Company Product Dictionary, WHO-DD)
- Responsible for writing medically relevant Safety narrative of cases and checking completeness and accuracy of medical data entered in various fields.
- Responsible for various reconciliations for cases every month.
- Other Responsibilities:
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Mentor and guide activities of Drug Safety Associate.
- High level of proficiency of all workflow tasks.
- Perform any other drug safety related activities as assigned.
Education
Bachelor's in Pharmacy - Pharmaceutical Sciences
Andhra University
Visakhapatnam 08.2011 - 08.2015
Skills
Strong analytical and communication skills
Good leadership skills
Good computer knowledge, mainly MS Office
Strong team player and interpersonal skills
Strong planning capacity
Proactivity: taking responsibility, active involvement Ability to understand customer requirement
Software
Arisg 63 and 74
TrackWise
Certification
Lean Six Sigma White Belt Certified
Timeline
Lean Six Sigma White Belt Certified
08-2022
Patient Safety Specialist
Alcon
05.2022 - Current
Drug Safety Specialist
Fidelity Health Services
02.2020 - 10.2020
Junior Data Analyst
Cognizant technology Solutions
04.2018 - 01.2020
Senior Drug Safety Associate
Bioclinica Safety and Regulatory Solutions (Synowledge Pv Service India Pvt. Ltd),
10.2015 - 03.2018
Professional development completed in [PG Diploma in Clinical Research and Pharmacovigilance].
08-2015
Bachelor's in Pharmacy - Pharmaceutical Sciences
Andhra University
08.2011 - 08.2015