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

ad0pnb@r.postjobfree.com

Mumbai

708-***-****/ 738-***-****

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.

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