Data Analyst Patient Safety
Resume:
Afrin Attar
Data Analyst
About Me
Professional Experience
Pharmacovigilance professional with 6+
years of domain experience.
Currently working as quality reviewer and
SME (subject mater expert)
Availability
1 month
Education Background
Skills
Master in Pharmacy
Bharati vidyapeeth college of
pharmacy, Kolhapur
Completed in 2016
My Contact
*****.*********@*****.***
Mumbai
linkedin.com/in/afrin-attar-
424869194
Cognizant Technology Solutions Data Analyst
2021 – Present
Quality review of, spontaneous, regulatory
authority, partner, combination and
device cases, legal cases (Medical
records, Plaintiff fact sheets and Civil
complaint reports), literature cases &
clinical trial cases.
Assessing correctness and completeness
of triage related fields
Assessing correctness and completeness
of medical history, adverse event and
laboratory data
Key responsibilities: As Quality Reviewer
Handling internal queries across workflows.
Helping associates and providing quick
resolution to their queries to prevent miss in
TAT timelines or Partner timelines.
Updating team regarding new updates from
Client, project conventions, different case
processing conventions.
Handling client escalations and queries
Training new joiners in case processing and
quality review
Mentoring of new joiners
Individual team meetings, updates and Q & A
session, one and one sittings etc.
Key responsibilities: As SME
Data understanding and
interpretation
Handling of small team
Problem solving
Argus safety database
Sapphire safety database
Excel and mailbox
Bachelor of Pharmacy
Bharati vidyapeeth college of
pharmacy, Kolhapur
Completed in 2014
GPAT qualified
AIR: 315
Processing of regulatory authority, Partner cases, Combination and device cases, Legal cases (Medical records, Plaintiff fact sheets and Civil complaint reports), Literature cases, clinical trial cases, deletion/ merger, pregnancy and invalid cases as per SOP. Complete end to end processing of the ICSR.
Narrative writing as per SOP.
Ensuring Regulatory Compliance and adhering to their guidelines. Use of MedDRA for accurate and proper adverse event coding. Part of Special teams for handling of legal, Swiss and Epipen cases. Mentoring of new joiners
Tracking of quality parameters of new joiners
Key responsibilities: As Case Processor
Cognizant Technology Solutions Junio Data Analyst 2019 – 2021
Tata Consultancy Services Patient safety specialist + 2017 – 2019
Processing of clinical trial and legal cases.
Understanding of clinical trial protocols and processing data accordingly Understanding of blinding and unblinding with respect to endpoints of the study. Handling global PV safety database (Sapphire) provided by the client. Handling of triage related activities- Intake and Case creation Categorization of cases based on seriousness and expectedness Prioritizing case processing as per seriousness and regulatory timelines. Writing safety narratives, including summarization of the essential details of the case on the basis of source document or data received on follow up. Quality review of finished cases
Key responsibilities: As Patient safety specialist + Assessing causality & expectedness of the
events.
Ensuring compliance to the regulatory
guidelines & client conventions.
Use of MedDRA for accurate & appropriate
coding of events, medical history and
laboratory data.
Giving real time quality feedbacks to
associates.
Ensuring correctness and completeness of the
case.
Awards
Noticeable Performance
for Quality and
Productivity for multiple
times
Winner of 'Aavishkar-
research convention.
Contact this candidate