FAIZA

SEC-86, Faridabad,(Haryana)121007 Mob- 9540180818,7065594040

faiza4567@gmail.com

PROFESSIONAL SUMMARY

Enthusiastic Pharmacist with 8 years of experience in Pharmacovigilance. Seeking a suitable position in

Pharmacovigilance Industry, Healthcare sector where my potential is matched with growth and strength of
the organization.

KEY SKILLS f

• Trained in MedDRA coding in accordance with “MedDRA Term Selection”.

• Interacting with appropriate client personnel to resolve issues related to the processing of ICSR's.
• ICSR and aggregate reporting timelines on ARGUS 8.2.1
• Data base worked on ARGUS, SAPPHIRE, AB CUBE, and Veeva Vault Safety Database (VS.)
• Knowledge of Sapphire data base and vaccine cases.
• Argus safety validation & reporting rules.
• Knowledge of Micro Office, Windows, MS Word, Power Point, and Excel etc.

WORK HISTORY f

5 Pharmalex Pvt. Ltd. Assistant Manager Jun 2021 to till now

4 Apcer Life Sciences Pharmacovigilance May2017 to May 2021
Associate
3 Wipro BPS Pharmacovigilance Officer Dec 2015 to May 2017
2 EXL Medical Summarizer Apr 2015 to Nov 2015
1 Children’s Care and Cure Pharmacist Jun 2014 to Apr2015
Centre

As Assistant Manager at Pharmalex

• Co-ordinate & communicate between the team members and Project Manager.
• Record, maintain and track the metrics for both team members and project performance.
• Delegate tasks and responsibilities to appropriate personnel.
• Allocation and Tracking of the cases.
• To ensure the cases are completed as per timelines specified in the SOPs.
• Tracking of TAT and Quality metrics of cases.
• Supports PM in performing root cause analysis of failed cases.
• Organizes periodic feedback sessions with the team members.
• Provides updates for process efficiency and compliance improvement updates.
• Expertise in Team Handling, Allocation and Prioritization of all type of ICSRs.
• Provide support and prepare for regulatory inspections and audits for Compliance and Quality
Assurance (QA).
• Maintain compliance with all required training and standard operating procedures
• The specialist to ensure that individual adverse event case reports are evaluated, investigated
and accurately computerized.
• Demonstrating end to end activities of pharmacovigilance to on-site clients at 3 locations: right
from case processing activities like Intake and triage to Distribution and Submission of Individual
Case Safety Reports (ICSR’s) across the safety database.
• Process training for Argus safety database, Subject matter expert, Point of Contact and an
Experienced Quality Reviewer with broad expertise in concepts of Pharmacovigilance.
• Resolving customer queries across any workflow activity or on case validations, report
generation or distribution and submission of cases.
• Training new resources with similar profile and giving timely updates within organization as well
as to customers.
• Resolving queries at both a case processing level as well as at a functional level across the safety
database.
• Involved in end to end preparation of a number of learner guides and other controlled
documents or guidelines for case processing and quality review activities.

As Pharmacovigilance officer at Apcer Life Sciences

• Performing Quality Check for the CT, Literature & Solicited and Spontaneous, serious/non-serious
cases.

• Evaluation/amendment of narrative in the analysis tab. HCP/Non-HCP follow-up activities, other

Company notification, F/U activity with other companies and Product complaint verification.

• Monitoring and guiding the case processors to process the cases in accordance with the requirement
of client by adhering to the appropriate guidelines and providing the solutions related to case processing
problems encountered by them individually.
• Entering source data in the database, Med DRA Coding and WHO DD coding.
• Quality review of spontaneous and solicited cases.
• Determine necessarily follow up for missing, discrepant, or additional information/source.
• Documentation for each case using medical, product and regulatory knowledge.
• Proper Narrative Writing and Med DRA coding of events.
• Performing significant corrections & merge cases as per guidelines set by the clients.
• Training sessions to new Joiner as per new updates.
• Add query & sent the query letter in Argus to the destination.
• Documentation in Contact log & case closure activity.

As Pharmacovigilance Officer at Wipro BPS

• Manage expedited ICSR and aggregate reporting timelines on ARGUS 7.0.7.
• Track all adverse event reports received and completed.
• Review and assess all source documents, and compile data in an adverse event report.
• Data enter report into the client safety database with the guidelines from the clients.
• Release report to client through client safety database.
• Performing follow-up activities with HCP, Non-HCP, and other company.
• Data migrated cases, Merge Cases, Medical Device cases including both Serious & Non-Serious.

As Medical Summarizer at EXL

• Summarizing new patient records to a high standard and within the ICPI's (Institute for Care and
Practice Improvement) agreed timescales based on Practice procedures.
• Using medical knowledge to correct mistakes found in existing patient records.
• Maintaining structure when recording new information.
As Pharmacist at Children’s Care and Cure Centre Pharmacist
• Dispensing medicines as per prescription & Record maintenance of products.
• To monitor drug storage conditions and to discard medicines as per their expiry date.

SCHOLASTIC f

Sr. Course Institute, University Percentage Year of Passing

No.
1. Bachelor of Pharmacy Uttar Pradesh Technical University 62 % 2014
2. B.Sc. Rohilkhand University Bareilly 60 % 2010
3. SSC U.P. Board Allahabad 58 % 2007
4. HSC U.P. Board Allahabad 55% 2005

ACCOMPLISHMENTS f
• Pharm Project- To study the Bacterial vaginosis by the PH in pregnant women by Florisia Gloves.
• Industrial Training: Training 1: Industrial Visit Organization: Richter Themis Medicare Pvt
Ltd., Vapi Section: API, R&D, QC
• Attended various Departmental seminars held in Department of Pharmacy, Ram-Eesh
Institute of Vocational and Technical Education, Greater Noida.
• Winners in various cultural & sport activities in College and School.
• Attended three days Seminar of Pharmacovigilance by Academy of Clinical intelligence-
ACI, 2014.

PROJECT PROFILE f

B. Pharm Project- To study the Bacterial vaginosis by the PH in pregnant women by Florisia gloves.

INDUSTRIAL TRAINING f

INDUSTRIAL TRAINING
• Attended various Departmental seminars held in Department of Pharmacy Ram-Eesh Institute of Voc.
and Tech. Education from Greater Noida.
• Winners in various cultural & sport activities in College and School.

Achievements

• Top performer.
• Used out of the box techniques for completion of the given targets.
Personal Attributes

• Self-starter with a high energy level and ability to work with all levels of individuals.
• Contributor in high-performing teams and can work in fast-paced environment.

PERSONAL DETAIL
• Current Address: Princess Park, Sec 86, Greater Faridabad, 121004
• D.O.B : 2nd Jan 1991
• Marital Status : Married

DECLARATION f

I hereby declare that all the information provided by me is true to the best of my knowledge and belief.

Place: Faridabad

Date: Signature: