Falak Naaz
New Delhi
Summary
I am a registered pharmacist with 4 years of experience as a drug safety associate and Medical Information and Communications Specialist Acquired professional knowledge, expertise, and creativity through sincerity and hard work. I am a knowledge-driven, enthusiastic, and flexible candidate. Always open to learning and supporting teamwork. I aim to enhance my experience and wish to put my determined efforts to be up to the mark of the challenges of the organization.
Overview
7
7
years of professional experience
Work History
Senior Quality Reviewer
4C PHARMA DRUG SAFETY SERVICES
09.2024 - Current
- Present quality validation of cases received via emails, voicemails, or calls from consumers or HCPs with inquiries related to AE, PQC, MI, or others.
- Providing feedback to the associates, and recommending improvement based on the processed cases.
- Assess and ensure the quality of products, services, or processes against established standards.
- Maintaining quality, ensuring compliance, and adherence to relevant standards such as GLP, GCP, or other industry regulations to meet the client's expectations.
Senior Drug Safety Associate (Medical Information & Communications)
4C PHARMA DRUG SAFETY SERVICES
09.2022 - 09.2024
- Handling medical information queries, and collecting information on medications and their safe and correct use.
- Assisting people requiring medical care, who have taken their sponsor's medication in a trial, post-marketing exposure to the drug, and providing information as needed.
- Training on SOPs and workflow instructions for the newly hired resources. Understand the requirements of the patients, and provide precise information.
- Complete case entries, including case narrative and coding from the MedDRA dictionary and WHO drug dictionary, as per applicable SOPs and client requirements. Provide QC support for the MICC.
- Respond to web-based and written inquiries from healthcare professionals, members, and consumers concerning the safety and effective use of all marketed products promptly.
- To identify and retrieve relevant data and information appropriate to answer the information requested. Act as a subject matter expert.
- Identify clinically relevant information, and prepare follow-up requests as needed. Receive, review, and process drug safety information based on regulations and conventions.
Assistant Clinical Coordinator
DOCTOR ALLIANCE (PHOENIX COMPLIANCE)
Dallas
06.2022 - 09.2022
- Working as an Onshore Assistant Clinical coordinator(clinician) in Doctor Alliance (Phoenix Compliance) situated in Dallas, TEXAS US.
- Taking care of the DME Referrals of the patients received on NEXT Gen EHR, created by Health care professionals by clearly approving it by the patients.
- Faxing the DME Referrals for the physicians and providing the required medical equipment to the patients.
- Regularly validating the Electronic Health records of the patients.
- Verification of patients' details and processing of clinical documents online for various projects.
- Recognition of the Physical Exam process and ability to record Exam details.
Research Intern
JAMIA HAMDARD UNIVERSITY
10.2021 - 07.2022
- Production and Characterization of Esat-6 containing Alveolar macrophages derived exosomes by sonication and purification by Affinity Column Chromatography.
- Characterized MTB Esat-6 containing exosomes to describe the role, exosomes play in TB infection and how the circulation of these dynamic vesicles can be harnessed for diagnostic purposes and vaccine development against the deadly disease.
Drug Safety Associate
WIPRO LTD
01.2021 - 05.2022
- Worked as a patient Interaction and drug safety associate for USDSU, ADR reporting, and narrative writing.
- Responsibilities include taking calls within SLA timings and accurately documenting all the information provided by the health care professionals and consumers to prepare reports based on Adverse Drug Reactions or other Anomalies.
- Handling of ARGUS Drug safety reporting for Canada DSU, Market research, Narrative writing, Data Entry, ADE, ADR reporting, Clinical research data collection, spontaneous cases, epidemiology studies, secondary research, cGMP, ICH guidelines.
Prescription Auditor
APOLLO HOSPITALS
07.2019 - 08.2019
- Carefully performed Dispensing of Medications
- Preparing Indents for the Inpatient & Outpatient Pharmacy
- As a narrative writer, responsible for writing medically relevant safety narratives of cases and checking the completeness and accuracy of the data entered in the safety tool.
- Receive information on Adverse events, and perform initial checks like Book in cases, search database to prevent duplicate entries, create case files, and initialize received drug safety reports in the safety database (ARGUS).
- As Medical Coder, responsible for coding all medical history, events, drugs/procedures/medications/laboratory testing according to the medical dictionary.
- Other responsibilities include following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow Departmental AE workflow procedures. Perform any other safety-related activities as assigned.
Industrial Trainee
ROSEATE MEDICARE
01.2019 - 02.2019
- Performed training in production & Quality departments with practical knowledge of BMR, BMP, SOP, GMP, and Analysis Tests.
- Observing the formulation procedure of medicines
- Observing the different packaging of dosage forms.
- Performed the Quality testing process of medicines.
Hospital Pharmacist
APOLLO HOSPITALS
06.2018 - 07.2018
- Prepared Medication Indents for the OT Pharmacy
- Keeping Day to Day records of Inventories
- Verify the purchase invoices, and stock received in the patient invoice.
Education
Post-Graduation Diploma - Pharmaceutical Drug Regulatory Affairs
JAMIA HAMDARD UNIVERSITY
01.2023
Master of Pharmacy - M Pharm Biotechnology
JAMIA HAMDARD UNIVERSITY
01.2022
Bachelor of Pharmacy - Pharmacy
IIMT COLLEGE OF PHARMACY
01.2020
Skills
- Medical information analysis
- Health and safety complaints
- Pharmacovigilance
- Narrative writing
- Aggregate reporting
- Good communication skills
Declaration
I hereby declare that the above-mentioned pieces of information are true and, to the best of my knowledge
Timeline
Senior Quality Reviewer
4C PHARMA DRUG SAFETY SERVICES
09.2024 - Current
Senior Drug Safety Associate (Medical Information & Communications)
4C PHARMA DRUG SAFETY SERVICES
09.2022 - 09.2024
Assistant Clinical Coordinator
DOCTOR ALLIANCE (PHOENIX COMPLIANCE)
06.2022 - 09.2022
Research Intern
JAMIA HAMDARD UNIVERSITY
10.2021 - 07.2022
Drug Safety Associate
WIPRO LTD
01.2021 - 05.2022
Prescription Auditor
APOLLO HOSPITALS
07.2019 - 08.2019
Industrial Trainee
ROSEATE MEDICARE
01.2019 - 02.2019
Hospital Pharmacist
APOLLO HOSPITALS
06.2018 - 07.2018
Post-Graduation Diploma - Pharmaceutical Drug Regulatory Affairs
JAMIA HAMDARD UNIVERSITY
Master of Pharmacy - M Pharm Biotechnology
JAMIA HAMDARD UNIVERSITY
Bachelor of Pharmacy - Pharmacy
IIMT COLLEGE OF PHARMACY
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