Neethu Benny
North York,Ontario
Summary
Pharmaceutical professional with 5+ years of experience in regulatory affairs, clinical research, medical writing, and pharmacovigilance. Currently pursuing a QA & RA course in Pharma, Food, and cosmetics. Demonstrated success in ensuring compliance with regulatory guidelines in healthcare product registration, coordinating approvals for the import of pharmaceuticals, and managing tender processes. Adept at scientific writing, analytical problem-solving, and negotiation. Seeking a role in pharmaceutical regulatory affairs, where I can leverage my regulatory, medical writing, clinical research, and pharmacovigilance experience to ensure compliance and product integrity.
Overview
6
6
years of professional experience
Work History
ASSOCIATE - REGULATORY AFFAIRS
AFLAG PHARMACY LLC
07.2020 - 06.2022
- Reviewed, compiled dossiers and other documents in compliance with the MOH regulatory guidelines for registration of health & nutritional products and cosmetics and medical devices
- Studied CTDs, scientific and legal documents and coordinated legalization of required regulatory documents adhering to Good Documentation Practice (GDocP)
- Handled 80+ product registrations across a spectrum including pharmaceuticals, natural health products, cosmetics and medical devices
- Prepared timelines and followed up document status with the stakeholders for completion of regulatory requirements
- Conducted physical analysis of sample and proposed change in product artworks and leaflet information
- Coordinated approvals for import of medicines, nutritional, health, medical device, cosmetics and consumables for Government and private institutions
- Developed medical device database as part of MOH Medical Device regulations 2020
- Supported biomedical division with medical device registration for PCR machine/ Rapid antigen test kit during COVID-19 outbreak
- Maintained files of registration certificates, renewal documents, temporary import approvals, and medical device import clearance documents.
ASSOCIATE - TENDERS & PROCUREMENT
AFLAG PHARMACY LLC
01.2019 - 06.2020
- Managed preparation and submission of high value bids, adhering to tender process and procurement guidelines for Government Institutions
- Awarded with annual purchase orders amounting to approximately 300,000 USD from govt
- Hospitals
- Negotiated with international stakeholders/suppliers to obtain quality products and services at the best prices by using sourcing strategies and extensive research thereby saving cost and maximized profitability
- Coordinated logistics and supply chain management
- Procurement of healthcare products (pharmaceutical, nutritional, health, medical devices, and cosmetic products) from international vendors
- Coordinated Regulatory audits at supplier facilities to ensure compliance with MOH regulatory standards.
JUNIOR ASSOCIATE - SCIENTIFIC WRITER
INDEGENE PVT. LTD.
07.2017 - 03.2018
- Provided healthcare solutions to biopharmaceutical companies such as Lupin, Sun pharma, Nestle, Abbott, GSK, Pfizer etc
- For marketing their products and services efficiently
- Reviewed, edited regulatory/ safety documents such as clinical study protocols, CSRs, aggregate reports, PSURs
- Prepared deliverables such as website articles, case reports, CME for HCPs and medical representatives
- Participated in client calls as per the project requirements
- Conducted literature reviews to identify appropriate references to support created scientific contents
- Developed and reviewed content for various deliverables with the quality requirements as per client satisfaction metrics within timeframe.
CLINICAL TRIAL COORDINATOR
BOEHRINGER INGELHIM / JSS HOSPITAL
01.2016 - 01.2017
- Assisted in screening, enrolling, and following study subjects, ensuring protocol compliance to ICH-GCP
- Processed regulatory and administrative documents of investigation sites
- Acted as a liaison for compiling and formatting clinical and regulatory data for submission to regulatory agencies in standardized format using electronic tools
- Managed dispensing and accountability of investigational product (Combination Drug & Medical Device) at the study site
- Contributed to the letters submitted to the Ethical Committee and prepared the site for Auditing
- Assisted in identifying suspected adverse drug reactions and problems/inconsistencies and monitored patients' progress
- Assessed suspected adverse events/serious adverse events using different causality assessment scales along with safety reporting of CIOMS and SUSARs.
Education
PG DIPLOMA - QA & RA - PHARMA, FOOD & COSMETICS
AAPS
Toronto, Ontario01.2023
PG DIPLOMA - PHARMACOVIGILANCE
JSS College Of Pharmacy
Mysore, India01.2016
M PHARM-PHARMACY PRACTICE - undefined
JSS College Of Pharmacy
Mysore, India01.2015
B PHARM - undefined
Govt. Medical College
Trivandrum, India01.2010
Skills
- Good Manufacturing Practices
- Regulatory compliance
- Quality Assurance
- QMS
- Post-market surveillance
- Pre-market Submission
- Change Control Management
- Validation & Qualification
- Document Control
- Time Management
- Scientific Writing
- Data Integrity
- ECTD & CTA
- NHP Regulation
- Medical Device Classification
- Good Documentation Practices
- Good Pharmacovigilance Practices
- MS Office (Word, Excel, PowerPoint)
- Medical devices regulation
- Project Management
- Procurement
- Adaptability
- Analytical & Problem Solving
- Attention to detail
- Organizational & Supervisory Skills
- ISO Standards
- Regulatory Submissions
- Document Management
Websites
Training
- Industrial site training on GMP, QC and QA from Unichem Laboratories Ltd. India.
- Training for ADR reporting to CDSCO at the regional Pharmaco-vigilance Centre (JSS Hospital) under National Pharmacovigilance Program (PVPI) by CDSCO using Vigiflow safety reporting management system.
- Establishment of Medication Information for Neuropsychiatric disorders and Sensitization Centre at Psychiatry OP Department (JSS Hospital, India) and provision of Clinical Pharmacy Services (DRP identification, ADR reporting, Medication Adherence and QOL evaluation and follow ups).
- Trained in RDC (Remote Data Capturing), ECRF (Electronic Case Report Form) and IWRS (Interactive Web Response System) by BoehringerIngelheim.
Timeline
ASSOCIATE - REGULATORY AFFAIRS
AFLAG PHARMACY LLC
07.2020 - 06.2022
ASSOCIATE - TENDERS & PROCUREMENT
AFLAG PHARMACY LLC
01.2019 - 06.2020
JUNIOR ASSOCIATE - SCIENTIFIC WRITER
INDEGENE PVT. LTD.
07.2017 - 03.2018
CLINICAL TRIAL COORDINATOR
BOEHRINGER INGELHIM / JSS HOSPITAL
01.2016 - 01.2017
PG DIPLOMA - QA & RA - PHARMA, FOOD & COSMETICS
AAPS
PG DIPLOMA - PHARMACOVIGILANCE
JSS College Of Pharmacy
M PHARM-PHARMACY PRACTICE - undefined
JSS College Of Pharmacy
B PHARM - undefined
Govt. Medical College
Similar Profiles
Mouath AlRahbiMouath AlRahbi
Deputy HR Manager at Aflag Pharmacy LLCDeputy HR Manager at Aflag Pharmacy LLC
Ravishekhar GeerRavishekhar Geer
Managing Director/Owner at Hope Medical Center LLC and Hope Pharmacy LLCManaging Director/Owner at Hope Medical Center LLC and Hope Pharmacy LLC
Eyad NehmaEyad Nehma
Warehouse & Procurement Specialist at OL Pharma Tech LLC / Drs PharmacyWarehouse & Procurement Specialist at OL Pharma Tech LLC / Drs Pharmacy
Kamran ZendeganiKamran Zendegani
C.E.O & Founder at Star Global Commerce canada Inc.C.E.O & Founder at Star Global Commerce canada Inc.
DUC AN TRANDUC AN TRAN
Intern at Reaching Up Jane and Finch, North YorkIntern at Reaching Up Jane and Finch, North York